HumaPen® Luxura™ HD MS9673Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00300029673019), received between Nov 21, 2017 and Jan 18, 2024 — classified as 85 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (32 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2024Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER, VIA A PATIENT SUPPORT PROGRAM, CONCERNED A 19-YEARS OLD MALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY WAS NOT REPORTED. THE CONCOMITANT MEDICATIONS INCLUDED TRESIBA ADMINISTERED FOR TYPE 1 DIABETES MELLITUS. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS, FROM A CARTRIDGE, SUBCUTANEOUSLY, DOSE DEPENDING UPON CARBOHYDRATES HE CONSUMED, IT COULD BE UP TO 40 UNITS AND AFTER A RANGE OF 281-380 MG/DL OF GLUCOSE, THE DOCTOR PRESCRIBED HIM TO INCREASE 5 MORE UNITS (FREQUENCY UNKNOWN), FOR THE TREATMENT OF TYPE 1 DIABETES MELLITUS, APPLIED IN THE STOMACH AND LEGS, VIA A REUSABLE PEN HUMAPEN LUXURA HALF DOSE PEN. HE ALSO RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG U100U/ML) VIA A PRE-FILLED PEN KWIKPEN, SUBCUTANEOUSLY, FOR TYPE 1 DIABETES, DOSE DEPENDING UPON CARBOHYDRATES HE CONSUMED. THERAPY START DATE AND FREQUENCY OF ADMINISTRATION WERE UNKNOWN. IT WAS REPORTED HE STARTED INSULIN LISPRO THERAPY SINCE AN UNKNOWN DATE IN (B)(6) 2018 (SPECIFIC THERAPY START DATES OF INSULIN LISPRO CARTRIDGE AND INSULIN LISPRO KWIKPEN WERE UNKNOWN). ON U

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 18535679 ↗
• InjuryJan 17, 2024Inaccurate Delivery; Mechanical Jam; Insufficient Device Problem Information; Inaccurate Delivery; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: (B)(6). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY TO REPORT AN ADVERSE EVENTS AND PRODUCT COMPLAINT, CONCERNED A 12-YEARS OLD FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. THE CONCOMITANT MEDICATION INCLUDED INSULIN DEGLUDEC ADMINISTERED FOR UNKNOWN INDICATION. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG) THROUGH A CARTRIDGE ADMINISTERED THRICE DAILY, 12 UNITS, 10 UNITS, AND 12 UNITS, SUBCUTANEOUSLY FOR THE TREATMENT OF DIABETES, VIA HUMAPEN LUXURA HD, BEGINNING ON AN UNKNOWN DATE IN 2015. ON AN UNKNOWN DATE, WHILE ON INSULIN LISPRO TREATMENT, THE HUMAPEN LUXURA HD NEEDED HIGH INJECTION FORCE DURING ADMINISTRATION AND DID NOT RELEASE ACCURATE INSULIN LISPRO DOSES WHICH LED TO ELEVATION IN BLOOD GLUCOSE LEVEL (PC NUMBER, (B)(4); LOT NUMBER, 1201G07). ON UNSPECIFIED DATE IN (B)(6) 2023, IT WAS REPORTED WHEN SHE ADMINISTERED FULL DOSE UNITS, SHE SUFFERED FROM HYPOGLYCEMIC COMA AS HER BLOOD GLUCOSE LEVEL DECREASED AROUND 100MG/DL FROM THE TOTAL BLOOD GLUCOSE LEVEL, WITH SYMPTOMS OF VOMITING AND LOSS OF CONSCIOUSNESS FROM TWO TO THREE WE

  Patient problems: Coma; Hypoglycemia

  MAUDE report 18527520 ↗
• InjuryDec 1, 2023Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: EG202311011909. THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT:(B)(4). THIS SPONTANEOUS CASE REPORTED BY CONSUMERS WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS AND A PRODUCT COMPLAINT (PC), CONCERNED A 07-YEAR-OLD PAEDIATRIC (AT THE TIME OF INITIAL REPORT) MALE PATIENT OF AN UNKNOWN ORIGIN. MEDICAL HISTORIES INCLUDED ELEVATED BLOOD GLUCOSE LEVEL DUE TO WHICH HE WAS HOSPITALIZED AND DIAGNOSED WITH DIABETES TYPE I IN 2019. CONCOMITANT MEDICATION INCLUDED INSULIN DEGLUDEC USED FOR THE TREATMENT OF DIABETES. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG, 100 U/ML), FROM A CARTRIDGE VIA HUMAPEN LUXURA HALF DOSE (HD) PEN, AT 2 INTERNATIONAL UNITS (IU) IN MORNING, 2 IU AT NOON AND 1 IU IN EVENING, ADMINISTERED SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES TYPE I BEGINNING ON AN UNKNOWN DATE IN 2019. APPROXIMATELY FROM ON AN UNKNOWN DATE IN 2018, HE STARTED USING HUMAPEN LUXURA HD PEN. ON AN UNKNOWN DATE IN 2022, WHILE ON INSULIN LISPRO THERAPY, HE EXPERIENCED HIS BLOOD GLUCOSE LEVEL WAS ELEVATED (EXACT VALUES, UNITS AND REFERENCE RANGES WERE UNKNOWN) DUE TO WHICH HE WAS HOSPITALIZED FOR 10 DAYS. THE DATE OF ADMISSION AND DISCHARGE WAS UNKNOWN

  Patient problems: Hyperglycemia

  MAUDE report 18247050 ↗
• InjuryOct 20, 2023Mechanical Jam; Mechanical Jam

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS, CONCERNED A 10-YEARS-OLD (AT THE TIME OF INITIAL REPORT) MALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTION (HUMALOG 100U/ML) FROM CARTRIDGE VIA HUMAPEN LUXURA HALF-DOSE (HD) PEN, AT AN UNKNOWN DOSE THREE TIMES PER DAY, SUBCUTANEOUSLY, FOR TYPE I DIABETES, BEGINNING ON AN UNSPECIFIED DATE IN 2019 OR 2020. ON AN UNKNOWN DATE, WHILE ON INSULIN LISPRO THERAPY, SHE EXPERIENCED THAT THE HUMAPEN DEVICE JAMMED AND WAS SO HEAVY WHILE PRESSING ON ITS BUTTON DURING DOSE ADMINISTRATION WHICH CAUSED MASSES AT HER INJECTION SITE ((B)(4)/ LOT 1208G08). THE CAREGIVER REPORTED THAT PATIENT'S DEVICE WAS SHARED WITH ANOTHER PATIENT AND STORED THE DEVICE IN THE REFRIGERATOR (IMPROPER USE). ON (B)(6) 2023, WHILE ON INSULIN LISPRO THERAPY HE EXPERIENCED HYPERGLYCEMIA (UNITS, VALUES AND REFERENCE RANGE WAS NOT PROVIDED) DUE TO WHICH HE WAS HOSPITALIZED FOR 48 HOURS AND DISCHARGED ON (B)(6) 2023. HE WAS FULLY RECOVERED FROM TH

  Patient problems: Hyperglycemia

  MAUDE report 17975348 ↗
• InjurySep 18, 2023Mechanical Problem; Mechanical Problem

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT AN ADVERSE EVENT AND PRODUCT COMPLAINT, CONCERNED A PEDIATRIC PATIENT OF UNKNOWN AGE, GENDER AND ORIGIN. MEDICAL HISTORY WAS NOT REPORTED. CONCOMITANT MEDICATIONS INCLUDED INSULIN GLARGINE FOR AN UNKNOWN INDICATION. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTION (HUMALOG 100U/ML) FROM CARTRIDGE VIA HUMAPEN LUXURA HD, FOR AN UNKNOWN INDICATION, BEGINNING ON AN UNSPECIFIED DATE. DOSE, ROUTE AND FREQUENCY WERE NOT PROVIDED. ON AN UNKNOWN DATE WHILE ON INSULIN LISPRO THERAPY PATIENT EXPERIENCED THAT HUMAPEN WAS BROKEN FROM THE PUSHING PART AT THE BACK OF THE DEVICE, THEREFORE THE PATIENT COULD NOT ADMINISTER INSULIN (PC (B)(4) / LOT UNKNOWN). ON (B)(6) 2023, WHILE ON INSULIN LISPRO THERAPY BLOOD GLUCOSE WAS MEASURED AT 750 (UNIT AND REFERENCE RANGE WAS NOT PROVIDED) DUE TO WHICH PATIENT WAS ADMITTED TO THE EMERGENCY SERVICE AND WAS ADMINISTERED INSULIN (TYPE OF INSULIN NOT PROVIDED). THE EVENT OF BLOOD GLUCOSE INCREASED WAS CONSIDERED AS SERIOUS BY THE COMPANY DUE TO ITS MEDICAL SIGNIFICANCE. INFORMATION REGARDIN

  Patient problems: Hyperglycemia

  MAUDE report 17765810 ↗
• InjuryJul 19, 2023Inaccurate Delivery; Insufficient Device Problem Information; Inaccurate Delivery; Insufficient Device Problem Information

  LILLY CASE ID: (B)(6). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM (PSP), CONCERNED A 3-YEAR-OLD FEMALE PATIENT OF AN UNKNOWN ETHNICITY. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG 100U/ML) CARTRIDGE VIA REUSABLE HUMAPEN LUXURA HALF-DOSE PEN, 6 UNITS -9 UNITS DEPENDS ON MEALS, SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES BEGINNING IN (B)(6) 2023. ON AN UNKNOWN DATE, WHILE ON INSULIN LISPRO, THE DEVICE DID NOT RELEASE ACCURATE DOSE BECAUSE THERE WAS DISTURBANCE IN BLOOD GLUCOSE LEVEL, ON (B)(6) 2023, SHE HAD BLOOD GLUCOSE LEVEL ELEVATED FROM 3 DAYS IN MORNING, DESPITE OF TAKING HER INSULIN DOSE. ALSO, THE BLOOD GLUCOSE LEVEL WAS DECREASED IN NIGHT WHICH REACHED 30-35MG/DL. THIS EVENTS WAS CONSIDERED TO BE SERIOUS BY THE COMPANY DUE TO ITS MEDICAL SIGNIFICANCE. IT WAS PERFORMED A (GLYCATED HAEMOGLOBIN) HBA1C LAB TEST ON (B)(6) 2023, AND ITS RESULT WAS 5.9MG/DL, AS PER THE PHYSICIAN IT WAS NORMAL RANGE. SHE WAS RECOVERING, BUT SHE USED TO SUFFER FROM DISTURBANCE IN BLOOD GLUCOSE LEVEL FREQUENTLY AS IT WAS HAPP

  Patient problems: Hypoglycemia

  MAUDE report 17350922 ↗
• InjuryJun 9, 2023Mechanical Problem; Failure to Deliver; Mechanical Problem; Failure to Deliver

  LILLY CASE ID: (B)(6). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER, VIA A PATIENT SUPPORT PROGRAM (PSP), CONCERNED A 2-YEAR-OLD MALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG U100/ ML) FROM CARTRIDGE VIA A REUSABLE DEVICE (HUMAPEN LUXURA HD), BEGINNING ON AN UNSPECIFIED DATE IN 2020 (THREE YEARS FROM (B)(6) 2023). DOSAGE, FREQUENCY, ROUTE OF ADMINISTRATION AND INDICATION FOR USE WERE NOT PROVIDED. SINCE APPROXIMATELY (B)(6) 2023, AFTER STARTING INSULIN LISPRO THERAPY, HIS BLOOD GLUCOSE LEVEL WAS HIGH WITH REPORTED VALUE OF 600 (UNITS AND REFERENCE RANGES WERE NOT PROVIDED). THE EVENT WAS CONSIDERED SERIOUS BY THE COMPANY DUE TO MEDICAL SIGNIFICANT REASONS. ON THE SAME DATE, IT WAS ALSO NOTICED SOMETHING (UNSPECIFIED) WITH THE HUMAPEN LUXURA HD AND AS OF (B)(6) 2023 OR (B)(6) 2023 (CONFLICTING INFORMATION PROVIDED) THE HUMAPEN LUXURA HD WAS DEFECTIVE BECAUSE IT DID NOT GIVE THE MEDICINE DUE TO THE DEGREE OF VENTILATION OF THE HUMAPEN (PRODUCT COMPLAINT (PC) (B)(4)/ LOT 1811G02). INFORMATION REGARDING CORRECTIV

  Patient problems: Hyperglycemia

  MAUDE report 17098761 ↗
• InjuryJun 2, 2023Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM (PSP), CONCERNED A 09-YEAR-OLD (AT THE TIME OF INITIAL REPORT) FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTION (HUMALOG 100U/ML) FROM UNKNOWN FORMULATION VIA REUSABLE PEN HUMAPEN LUXURA HD, 5 UNITS IN MORNING, 8 UNITS AT NOON AND 2 UNITS AT NIGHT, SUBCUTANEOUSLY, FOR THE TREATMENT OF TYPE ONE DIABETES MELLITUS, BEGINNING ON AN UNSPECIFIED DATE IN 2017. ON (B)(6) 2023, WHILE ON INSULIN LISPRO THERAPY SHE EXPERIENCED THAT THE PEN DID NOT RELEASE INSULIN WHICH RESULTED IN ELEVATION IN BLOOD GLUCOSE LEVEL, REACHED UP TO 500MG/DL (REFERENCE RANGE WAS NOT PROVIDED). THE PEN SCREW WAS STUCK AND IT WAS NOT WORKING PROPERLY SO NO INSULIN WAS RELEASED (PC 6490372/LOT 1208G08). SHE STORED THE PEN IN THE REFRIGERATOR WHEN THE WEATHER WAS HOT AND CHANGES THE PEN NEEDLE EVERY THREE DAYS (IMPROPER USE AND STORAGE). ON (B)(6)2023 SHE WAS HOSPITALIZED DUE TO THE BLOOD GLUCOSE INCREASED. SHE RECEIVED INTRAVENOUS SALINE SOLUTION IN THE HOSPIT

  Patient problems: Hyperglycemia

  MAUDE report 17049805 ↗
• InjuryApr 4, 2023Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: (B)(6). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SPONTANEOUS CASE DEVICE ONLY, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS AND PRODUCT COMPLAINT (PC), CONCERNED A MALE PATIENT OF UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY INCLUDED DIABETES. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECIEVED UNSPECIFIED INSULIN VIA A REUSABLE PEN HUMAPEN LUXURA HD (HALF DOSE). GENERIC NAME, TYPE OF INSULIN, FORMULATION, DOSAGE, FREQUENCY OF USE, ROUTE OF ADMINISTRATION, INDICATION FOR USE AND START DATE OF THERAPY WERE NOT PROVIDED. ON AN UNKNOWN DATE, UNKNOWN TIME AFTER STARTING UNSPECIFIED INSULIN THERAPY WITH HUMAPEN LUXURA HD, THE DEVICE CRASHED AND HE WAS NOT ABLE BUY A NEW ONE (PC (B)(4) / LOT UNKNOWN). ALSO, ON AN UNSPECIFIED DATE, HE EXPERIENCED A LACK OF BLOOD GLUCOSE CONTROL AND FAINTED. ON AN UNSPECIFIED DATE AND DUE TO THE EVENTS, HE WAS HOSPITALIZED, HE SPENT FIVE DAYS IN THE INTENSIVE CARE UNIT (ICU), AND THEN FIVE DAYS IN THE APARTMENT (AS REPORTED). ON AN UNSPECIFIED DATE, HE WAS DISCHARGED AND BY 21-MAR-2023, HE WAS ALREADY AT HOME. INFORMATION REGARDING HOSPITALIZATION DATES, LABORATORY EXAMINATION FINDIN

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 16676076 ↗
• InjuryMar 31, 2023Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM (PSP), CONCERNED A 03-YEAR-OLD (AT THE TIME OF INITIAL REPORT) MALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTION (HUMALOG 100U/ML) FROM CARTRIDGE VIA HUMAPEN LUXURA HD, AT UNKNOWN DOSE, THREE TIMES A DAY, SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON AN UNSPECIFIED DATE IN APR-2018. ON AN UNKNOWN DATE IN 2018, WHILE ON INSULIN LISPRO THERAPY, HIS BLOOD GLUCOSE LEVEL WAS 1017 (UNITS AND REFERENCE RANGE WAS NOT PROVIDED) DUE TO WHICH HE WENT TO THE HOSPITAL. HIS BLOOD GLUCOSE LEVEL REMAINED HIGH CONSTANTLY BECAUSE OF THE PATIENT EATING SUGAR THINGS. ON (B)(6) 2023, THERE WAS HARDENING IN THE HUMAPEN LUXURA HD, AND HE HAD DIFFICULTY WITH HUMAPEN LUXURA HD. THE APPLICATION PEN WAS ABOUT TO DETERIORATE, THE APPLICATION PEN HEAD HAD HARDENED, AND IT WAS HARD TO PRESS (PC NUMBER: (B)(4), LOT NUMBER: UNKNOWN). HE HAD BEEN USING AYSET AS A NEEDLE TIP BRAND. ON AN UNKNOWN DATE, HE WAS EATING SUGAR THINGS AND THEREF

  Patient problems: Hyperglycemia

  MAUDE report 16659595 ↗
• InjuryMar 31, 2023Failure to Deliver; Mechanical Jam; Failure to Deliver; Mechanical Jam

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS AND PRODUCT COMPLAINT (PC), CONCERNED A 64-YEARS-OLD (AT THE TIME OF INITIAL REPORT) PATIENT OF UNKNOWN GENDER OF HAN NATIONALITY. MEDICAL HISTORIES INCLUDED HEART DISEASE AND HYPERTENSION. THERE WAS NO PREVIOUS DRUG ADVERSE REACTION AND NO FAMILY DRUG REACTION. CONCOMITANT MEDICATIONS INCLUDED UNSPECIFIED MEDICATION USED FOR UNKNOWN INDICATION. THE PATIENT RECEIVED INSULIN LISPRO PROTAMINE SUSPENSION 50%/INSULIN LISPRO 50% (RDNA ORIGIN) FROM CARTRIDGE (HUMALOG 50, 300 IU/3ML), VIA A REUSABLE PEN (HUMAPEN ERGO II), AT DOSE OF 18 UNITS IN MORNING, 18 UNITS IN EVENING, SUBCUTANEOUSLY, FOR TREATMENT OF DIABETES MELLITUS, BEGINNING ON AN UNKNOWN DATE IN (B)(6) 2016. ON AN UNKNOWN DATE, ACCORDING TO ADVICE OF DOCTOR DOSE OF PATIENT WAS CHANGED TO 24 UNITS IN MORNING AND 24 UNITS IN EVENING. ON AN UNKNOWN DATE, AFTER STARTING INSULIN LISPRO PROTAMINE SUSPENSION 50%/INSULIN LISPRO 50% THERAPY, PATIENT'S CONDITIONS OF HEART DISEASE AND HYPERTENSION WORSENED. ON (B)(6) 2023, INJECTION SCREW OF HUMAPEN ERGO II COULD

  Patient problems: Hyperglycemia

  MAUDE report 16658165 ↗
• InjuryMar 7, 2023Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM (PSP), CONCERNED A 07-YEAR-OLD PEDIATRIC FEMALE PATIENT OF AN UNKNOWN ORIGIN. MEDICAL HISTORY NOT PROVIDED. CONCOMITANT MEDICATION INCLUDED INSULIN GLARGINE FOR DIABETES MELLITUS. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) (HUMALOG 100 U/ML) FROM A CARTRIDGE USING REUSABLE PEN HUMAPEN LUXURA HD, WITH CHANGEABLE DOSAGE AND FREQUENCY VIA UNKNOWN ROUTE FOR THE TREATMENT OF DIABETES MELLITUS BEGINNING ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, AFTER STARTING INSULIN LISPRO THERAPY, SHE EXPERIENCED THAT HER BLOOD GLUCOSE LEVEL REMAINED VERY HIGH DURING A DAY, THE BLOOD GLUCOSE LEVEL DID NOT DECREASE AND INCREASED TO 400-500 (NO UNITS AND REFERENCE RANGE PROVIDED) WHEN THE APPLICATION PEN WAS CHECKED, IT WAS UNDERSTOOD THAT THE BLACK STICK WAS NOT PUSH THE MEDICINE (BATCH UNKNOWN, (B)(4)), SHE WAS ADMITTED TO THE HOSPITAL AT NIGHT AS A PRECAUTION. AT THE HOSPITAL, PHYSICIAN PRESCRIBED INSULIN LISPRO KWIKPEN AND A NEW HUMAPEN ERGO II WAS SENT. THE BLOOD GLUCOSE LEVEL WAS RETURNED TO NORMAL LEVEL HOWEVER SHE REMAINED ILL FOR FEW DAYS

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 16496444 ↗
• InjuryFeb 23, 2023Mechanical Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information; Mechanical Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER, VIA A PATIENT SUPPORT PROGRAM, CONCERNED A FEMALE PATIENT OF UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY INCLUDED TYPE 1 DIABETES MELLITUS. THE CONCOMITANT MEDICATION WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG), FROM A CARTRIDGE, BEGINNING SINCE AN UNKNOWN DATE, VIA A REUSABLE PEN HUMAPEN LUXURA HALF DOSE PEN, BEGINNING SINCE AN UNKNOWN DATE. DOSAGE REGIMEN, ROUTE OF ADMINISTRATION, THERAPY START DATES AND INDICATION OF USE WERE UNKNOWN. ON AN UNSPECIFIED DATE IN (B)(6) 2023, SHE WAS HOSPITALIZED FOR TEN DAYS DUE TO DIABETES AND SHE WAS SICK WITH FEVER. SINCE AN UNKNOWN DATE, WHILE ADMINISTERING INSULIN LISPRO, HER APPLICATION PEN WAS DEFECTIVE, WHEN SHE TRIED TO APPLY ONE OR TWO DROPS CAME FROM THE PEN AND SINCE (B)(6) 2023, HER BLOOD SUGAR ROSE TO 350-400 (UNITS AND REFERENCE RANGE NOT PROVIDED) FOR THREE DAYS. ON (B)(6) 2023, HER BLOOD GLUCOSE INCREASED, AND IT WAS NOT LIKE PREVIOUS. SHE REPORTED HER BLOOD GLUCOSE DID NOT INCREASE LIKE THAT NORMALLY AND SHE CHECKED IF THERE WAS A PROBLEM WITH THE APPLICATION PEN.

  Patient problems: Hyperglycemia

  MAUDE report 16432683 ↗
• InjuryFeb 22, 2023Fitting Problem; Insufficient Device Problem Information; Fitting Problem; Insufficient Device Problem Information

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM (PSP), CONCERNED A 2-YEAR-OLD INFANT MALE PATIENT OF AN UNKNOWN ORIGIN. MEDICAL HISTORY INCLUDED TYPE-I DIABETES MELLITUS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG 100 U/ML) FROM CARTRIDGE VIA A REUSABLE DEVICE (HUMAPEN LUXURA HALF-DOSE DEVICE), SUBCUTANEOUSLY FOR THE TREATMENT OF TYPE-I DIABETES MELLITUS BEGINNING ON AN UNKNOWN DATE APPROXIMATELY IN (B)(6) 2021. DOSE AND FREQUENCY WERE NOT PROVIDED. FROM ON AN UNKNOWN DATE, APPROXIMATELY SINCE (B)(6) 2021, HE STARTED TO USE THE HUMAPEN LUXURA HD DEVICE. ON AN UNKNOWN DATE, STARTING THE INSULIN LISPRO THERAPY, THE NEEDLE ATTACHED TO HUMAPEN LUXURA HD DEVICE WAS SLIDING AND DID NOT FIT THE APPLICATION PEN CONSTANTLY. THE NEEDLE TIP PART OF THE APPLICATION PEN WAS DEFORMED, AND THE PEN WAS DEFECTIVE (B)(4); LOT-1811G02). APPROXIMATELY SINCE (B)(6) 2023, HIS BLOOD GLUCOSE LEVEL WAS IMBALANCE AND WAS INCREASING AND DECREASING. AS OF (B)(6) 2023, THE BLOOD GLUCOSE LEVEL WAS 35 (UNIT AND REFERENCE RANGE WERE NOT PR

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 16420853 ↗
• InjuryFeb 21, 2023Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS AND A PRODUCT COMPLAINT (PC), CONCERNED 04-YEAR-OLD PEDIATRIC (AT THE TIME OF INITIAL REPORT) MALE PATIENT. MEDICAL HISTORY INCLUDED DIABETES MELLITUS DIAGNOSED ON (B)(6) 2022. CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG, 100 U/ML), FROM A CARTRIDGE VIA HUMAPEN LUXURA HALF DOSE (HD) PEN, AT AN UNKNOWN DOSE IN MORNING AND NOON (POSSIBLY 3 IU BUT NOT CONFIRMED) AND 6 INTERNATIONAL UNITS (IU) IN EVENING, SUBCUTANEOUSLY FOR THE TREATMENT OF DIABETES MELLITUS BEGINNING ON (B)(6) 2022. ON 13-OCT-2022, HE STARTED USING HUMAPEN LUXURA HALF DOSE PEN. ON AN UNKNOWN DATE, AFTER STARTING THE INSULIN LISPRO THERAPY, SUDDENLY HIS BLOOD GLUCOSE LEVEL WAS INCREASED TO 400 AFTER APPLICATION OF NORMAL DOSE OF 3 IU BEFORE MEAL. IT WAS NOT SUPPOSED TO INCREASE LIKE THIS, AND SHE REALIZED IT WAS DUE TO APPLICATION PEN WAS JAMMED AND DID NOT KNOW HOW MUCH OF THE DOSE THE APPLICATION PEN GAVE TO HIM (PC: 6329822, 6329823 /LOT: 1811G02, D478176D) (INCORRECT DOSE ADMINIST

  Patient problems: Hyperglycemia

  MAUDE report 16409803 ↗
• InjuryFeb 13, 2023Mechanical Jam; Mechanical Jam

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY VIA A PATIENT SUPPORT PROGRAM (PSP) TO REPORT ADVERSE EVENTS AND A PRODUCT COMPLAINT (PC), CONCERNED A PEDIATRIC FEMALE PATIENT OF UNKNOWN AGE AND ETHNICITY. MEDICAL HISTORY INCLUDED USUALLY GOT REPEATED COMMON COLD DURING THE WINTER SEASON AND NEED TO GO HOSPITAL EVERY TIME FOR TAKING INTRAVENOUS (IV) FLUIDS TO DECREASE THE BLOOD GLUCOSE LEVEL AND DIABETES DIAGNOSED IN JUN-2017. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTION (HUMALOG, 100MG) CARTRIDGE, VIA A HUAMPEN LUXURA HALF-DOSE (HD) DEVICE, AT A DOSE OF 100MG, AT AN UNKNOWN FREQUENCY (DEPEND ON THE MEAL), SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES, BEGINNING ON AN UNKNOWN DATE IN (B)(6) 2017. ON AN UNKNOWN DATE, WHILE ON INSULIN LISPRO THERAPY, SHE SUFFERED FROM REPEATED ELEVATION IN BLOOD GLUCOSE LEVEL REACHED TO 500MG/DL OR HIGH READING (FIRST EPISODE), IF SHE GOT ANY INFLAMMATION IN HER BODY, TEETH PAIN, OR EATING SOME SPECIFIC FOODS (UNSPECIFIED) AND IMMUNITY WEAKNESS. SINCE AN UNKNOWN DATE IN (B)(6)2022, WHILE ON

  Patient problems: Hyperglycemia

  MAUDE report 16364133 ↗
• InjuryDec 5, 2022Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: (B)(6). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER, VIA A PATIENT SUPPORT PROGRAM (PSP), CONCERNED A 13-YEARS FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY INCLUDED DIABETES MELLITUS DIAGNOSED SINCE AN UNKNOWN DATE IN 2021. LAB VALUES WERE UNKNOWN. THE CONCOMITANT MEDICATION INCLUDED INSULIN GLARGINE ADMINISTERED FOR DIABETES MELLITUS. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG), FROM A CARTRIDGE, 11 UNITS OR 12 UNITS BEGINNING ON (B)(6) 2009, VIA A REUSABLE PEN HUMAPEN LUXURA HALF DOSE PEN, BEGINNING SINCE AN UNKNOWN DATE IN 2021, SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES MELLITUS. SINCE AN UNKNOWN DATE, THE BACK OF THE HUMAPEN LUXURA HALF DOSE PEN HAD BEEN PRESSING VERY HARD AND IT WAS STUCK AND THERE WAS NO MEDICINE COMING FROM THE TIP. ON (B)(6) 2022, WHILE ADMINISTERING INSULIN LISPRO, THE APPLICATION PEN DID NOT GIVE THE DRUG AND HER BLOOD GLUCOSE INCREASED TO 650 (UNITS, AND REFERENCE RANGE NOT PROVIDED) AND SHE WAS HOSPITALIZED BECAUSE OF IT (LOT. NO. 1809G01, PC. NO. (B)(4). HUMA PEN ERGO II APPLICATION PEN WAS GIVEN TO HER DURING HOSPITALIZATION AND HER BLOOD GLUCO

  Patient problems: Hyperglycemia

  MAUDE report 15914566 ↗
• InjuryDec 2, 2022Excess Flow or Over-Infusion; Insufficient Device Problem Information; Excess Flow or Over-Infusion; Insufficient Device Problem Information

  LILLY CASE ID: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM (PSP), CONCERNED A 40-YEAR-OLD FEMALE PATIENT OF AN UNKNOWN ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. THE CONCOMITANT MEDICATION INCLUDED TACROLIMUS AND AZATHIOPRINE FOR THE TREATMENT FOR KIDNEY, METHYLPREDNISOLONE FOR THE UNKNOWN INDICATION, LANSOPRAZOLE FOR THE TREATMENT FOR STOMACH AND INSULIN GLARGINE FOR THE TREATMENT OF DIABETES MELLITUS. THE PATIENT RECEIVED HUMAN INSULIN (RDNA ORIGIN) INJECTIONS (HUMULIN R 100 UNITS/ML) THROUGH A CARTRIDGE, VIA A REUSABLE PEN (HUMAPEN ERGO-II), 6 INTERNATIONAL UNITS (IU) EACH MORNING AND 9 INTERNATIONAL UNITS AT NOON AND EACH EVENING, FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON AN UNKNOWN DATE IN 1991. ON AN UNKNOWN DATE IN 2008 AFTER STARTING HUMAN INSULIN THERAPY, SHE UNDERWENT KIDNEY TRANSPLANTATION AND ON AN UNKNOWN DATE IN 2009, SHE UNDERWENT PANCREAS TRANSPLANTATION, BOTH FOR UNKNOWN REASONS. AFTER THE PANCREAS TRANSPLANTATION, SHE GAVE A BREAK TO INSULIN THERAPY AND RESTARTED THE HUMAN INSULIN THERAPY IN 2013. ON AN UNKNOWN DATE, HER HUMAPEN ERGO-II DEVICE WAS PRESSED HARDLY, THUS A NEW APPLICATION PEN WAS REQUESTED. ON (B)(6) 20

  Patient problems: Coma; Hypoglycemia

  MAUDE report 15908000 ↗
• InjuryDec 1, 2022Failure to Deliver; Mechanical Jam; Insufficient Device Problem Information; Failure to Deliver; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4) THIS SOLICITED CASE REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM (PSP), CONCERNED A 11-YEARS-OLD MALE PATIENT OF AN UNKNOWN ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS INCLUDED INSULIN GLARGINE FOR DIABETES MELLITUS. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG) CARTRIDGE VIA A REUSABLE PEN HUMAPEN LUXURA HALF DOSE (HD) PEN, UNKNOWN DOSE AND ROUTE FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON AN UNKNOWN DATE. ON (B)(6) 2022 WHILE ON INSULIN LISPRO TREATMENT, HE FELT STICK INSIDE THE APPLICATION PEN DID NOT MOVE, AND APPLICATION PEN DID NOT DELIVER THE MEDICINE AFTER CHANGING THE CARTRIDGE. HIS BLOOD GLUCOSE ELEVATED 700S. HE ALREADY HAD A HIGH GLUCOSE LEVEL AND COULD EASILY FALL INTO A COMA (PC NUMBER- (B)(4) AND LOT NO-1808G01). THE EVENT OF BLOOD GLUCOSE HIGH WAS CONSIDERED AS SERIOUS BY COMPANY DUE TO MEDICAL SIGNIFICANCE REASON. NOW HE WAS RECEIVING ONLY INSULIN GLARGINE AND BLOOD GLUCOSE WAS AROUND 200 WHEN SHE WAS LAST MEASURED. INFORMATION REGARDING CORRECTIVE TREATMENT, OUTCOME OF EVENTS AND STATUS OF INSULIN LISPRO TREATMENT WAS NOT

  Patient problems: Hyperglycemia

  MAUDE report 15894180 ↗
• InjuryNov 4, 2022Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER VIA PATIENT SUPPORT PROGRAM (PSP), CONCERNED A 06-YEARS-OLD MALE PATIENT OF AN UNKNOWN ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATION INCLUDED INSULIN GLARGINE FOR THE TREATMENT OF DIABETES MELLITUS. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG 100U/ML) VIA CARTRIDGE VIA A REUSABLE PEN (HUMAPEN LUXURA HD), 1 INTERNATIONAL UNIT (IU) THREE TIMES A DAY (SLIDING SCALE), SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES MELLITUS BEGINNING IN (B)(6) 2018. ON AN UNKNOWN DATE IN (B)(6) 2021 WHILE ON INSULIN LISPRO THERAPY, THERE WAS ONE TO TWO LITTLE BUBBLES INSIDE THE CARTRIDGE, APPLICATION WAS ARRANGED TO 1 IU, BUT IT GAVE LIKE 0.5 IU DRUG AND BLOOD SUGAR WAS INCREASING TO 400-500 (REFERENCE RANGE WAS NOT PROVIDED). THE EVENT OF BLOOD SUGAR INCREASED WAS CONSIDERED AS SERIOUS BY THE COMPANY DUE TO MEDICALLY SIGNIFICANT REASON. HIS BLOOD SUGAR LEVEL WAS HIGH ALTHOUGH HE WAS INJECTED 2IU INSULIN INSTEAD OF 1IU INSULIN. IF THERE WERE NO AIR BUBBLES IN THE CARTRIDGE HIS BLOOD SUGAR WAS FINE. A NEW CARTRIDGE ATTACHED AND THERE WAS

  Patient problems: Hyperglycemia

  MAUDE report 15725612 ↗
• InjuryNov 3, 2022Failure to Deliver; Mechanical Jam; Failure to Deliver; Mechanical Jam

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMERS WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENT AND PRODUCT COMPLAINT (PC), CONCERNED A MALE PATIENT OF UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) (HUMALOG 100U/ML) CARTRIDGE VIA A REUSABLE HUMAPEN LUXURA HD PEN, FOR THE TREATMENT OF AN UNKNOWN INDICATION, BEGINNING ON AN UNKNOWN DATE. DOSE AND FREQUENCY WERE NOT PROVIDED. ON AN UNKNOWN DATE, AFTER STARTING THE INSULIN LISPRO TREATMENT, THE HUMAPEN LUXURA HD PEN WAS NOT DISPENSING INSULIN LISPRO. THE PLUNGER DID NOT WENT DOWN, BUT THE DOSE SELECTOR KNOB AND INJECTOR WERE OPERATING NORMALLY. DUE TO THIS ISSUE, ON UNKNOWN DATE, THE PATIENT EXPERIENCED HIGH GLUCOSE (PC (B)(4), LOT NUMBER 1706G06) AND WAS HOSPITALIZED FOR ONE DAY. ACCORDING TO REPORTER, THE INCREASE IN THE GLUCOSE RATE WAS DUE TO THE PROBLEM IN THE HUMAPEN LUXURA HD PEN. DURING THE INITIAL REPORT, A TROUBLESHOOTING WAS PERFORMED WITH DEVICE, SO THE PLUNGER WAS RELEASED AND THE DEVICE WAS ABLE TO DISPENSE THE INSULIN LISPRO AGAIN. IT WAS STATED THE N

  Patient problems: Hyperglycemia

  MAUDE report 15723167 ↗
• InjuryAug 30, 2022Mechanical Problem; Inaccurate Delivery; Mechanical Problem; Insufficient Flow or Under Infusion; Inaccurate Delivery; Mechanics Altered

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER, VIA A PATIENT SUPPORT PROGRAM, CONCERNED A 1-YEAR-OLD MALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY WAS UNKNOWN. THE CONCOMITANT MEDICATIONS INCLUDED INSULIN GLARGINE ADMINISTERED FOR DIABETES MELLITUS. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG U 100), FROM A CARTRIDGE, BEGINNING ON AN UNKNOWN DATE IN (B)(6) 2022 (APPROXIMATELY), VIA A REUSABLE PEN HUMAPEN LUXURA HALF-DOSE PEN, BEGINNING SINCE AN UNKNOWN DATE IN (B)(6) 2022, 0.5 INTERNATIONAL UNITS, ADMINISTERED FOUR TIMES A DAY, SUBCUTANEOUSLY, FOR THE TREATMENT OF TYPE 1 DIABETES MELLITUS. ON AN UNKNOWN DATE, WHILE ON INSULIN LISPRO THERAPY, HIS BLOOD SUGAR DROPPED TO 39 (UNITS AND REFERENCE RANGE NOT PROVIDED). ON (B)(6) 2022, THE APPLICATION PEN MALFUNCTIONED, PROBABLY BECAUSE THE DOSE WAS 0.5 UNITS, HOWEVER THE APPLICATION PEN GAVE A SINGLE DROP INSTEAD OF GIVING 1-2 DROPS AND HIS DOSE WAS MISSED (LOT. NO, 1811G02, (B)(4)). ON (B)(6) 2022, HIS BLOOD SUGAR WAS 280 (UNITS AND REFERENCE RANGE NOT PROVIDED). IT WAS REPORTED THAT GRAY AREA AT THE PRESSURE POINT ON THE BACK OF TH

  Patient problems: Hypoglycemia

  MAUDE report 15321764 ↗
• InjuryJun 21, 2022Mechanical Jam; Break; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device Dislodged or Dislocated; Mechanical Jam

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS AND PRODUCT COMPLAINTS (PC), CONCERNS A FEMALE PATIENT OF AN UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY INCLUDED DIABETES. THE CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED HUMAN INSULIN ISOPHANE SUSPENSION 70%/HUMAN INSULIN 30% (RDNA ORIGIN) (HUMULIN 70/30) FROM A CARTRIDGE VIA A REUSABLE DEVICE (HUMAPEN LUXURA HD) FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON AN UNKNOWN DATE. INFORMATION REGARDING DOSE, FREQUENCY AND ROUTE OF ADMINISTRATION WAS NOT PROVIDED. ON AN UNKNOWN DATE IN 2021, SHE HAD LOW BLOOD GLUCOSE LEVEL (UNITS, VALUES AND REFERENCE RANGE NOT PROVIDED). SHE NORMALLY COULD WAIT UP TO HALF AN HOUR BEFORE FOOD BEFORE USING THE INSULIN; HOWEVER, BY THE TIME SHE GOT TO THE FRIDGE TO TAKE HER INSULIN OUT, SHE WAS UNCONSCIOUS. IT TOOK THE AMBULANCE THREE HOURS TO REVIVE HER. SHE INFORMED THIS WAS DUE TO LOW BLOOD GLUCOSE LEVEL AND THEY STUFFED GLUCOSE IN HER MOUTH. SHE ALSO REPORTED THAT SHE HAS SAW HER ENDOCRINOLOGIST FREQUENTLY FOR MANY YEARS WHO ADVISED THAT SHE MAY NEED TO

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 14755949 ↗
• InjuryJun 21, 2022Mechanical Jam; Device Fell; Defective Device; Mechanical Jam; Device Fell

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS AND PRODUCT COMPLAINTS (PC), CONCERNS A FEMALE PATIENT OF AN UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY INCLUDED DIABETES. THE CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED HUMAN INSULIN ISOPHANE SUSPENSION 70%/HUMAN INSULIN 30% (RDNA ORIGIN) (HUMULIN 70/30) FROM A CARTRIDGE VIA A REUSABLE DEVICE (HUMAPEN LUXURA HD) FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON AN UNKNOWN DATE. INFORMATION REGARDING DOSE, FREQUENCY AND ROUTE OF ADMINISTRATION WAS NOT PROVIDED. ON AN UNKNOWN DATE IN 2021, SHE HAD LOW BLOOD GLUCOSE LEVEL (UNITS, VALUES AND REFERENCE RANGE NOT PROVIDED). SHE NORMALLY COULD WAIT UP TO HALF AN HOUR BEFORE FOOD BEFORE USING THE INSULIN; HOWEVER, BY THE TIME SHE GOT TO THE FRIDGE TO TAKE HER INSULIN OUT, SHE WAS UNCONSCIOUS. IT TOOK THE AMBULANCE THREE HOURS TO REVIVE HER. SHE INFORMED THIS WAS DUE TO LOW BLOOD GLUCOSE LEVEL AND THEY STUFFED GLUCOSE IN HER MOUTH. SHE ALSO REPORTED THAT SHE HAS SAW HER ENDOCRINOLOGIST FREQUENTLY FOR MANY YEARS WHO ADVISED THAT SHE MAY NEED TO

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 14755858 ↗
• InjuryJun 2, 2022Mechanical Jam; Mechanical Jam

  LILLY CASE ID: (B)(6). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: (B)(4). THIS DEVICE ONLY SPONTANEOUS CASE, REPORTED BY A PATIENT WHO CONTACTED THE COMPANY TO REPORT AN ADVERSE EVENT AND PRODUCT COMPLAINT, CONCERNED A MALE PATIENT OF UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATION WAS NOT PROVIDED. THE PATIENT RECEIVED UNSPECIFIED INSULIN VIA A REUSABLE PEN HUMAPEN LUXURA HD WITH UNKNOWN DOSE, ROUTE, FREQUENCY AND INDICATION BEGINNING ON AN UNKNOWN DATE. ON AN UNKNOWN DATE WHILE ON HUMAPEN LUXURA HD PEN, HE EXPERIENCED THAT THE PEN HAD JAMMED THERE WAS NOT ENOUGH INSULIN LEFT IN THE CARTRIDGES, THEREFORE THERE WAS A NUMBER DISPLAYING IN THE DOSE WINDOW, HE INJECTED HIMSELF AND WENT INTO A COMA (BATCH # UNKNOWN PC# (B)(4)).THE PATIENT CONTINUED TO USE THE DEVICE AFTER EXPERIENCING THE COMPLAINT ISSUE AND APPLIED LUBRICATION TO THE PEN. THE EVENT OF COMA WAS CONSIDERED AS SERIOUS BY THE COMPANY DUE TO MEDICALLY SIGNIFICANT REASON. HE WAS FEELING FINE AFTER WAKING UP. INFORMATION REGARDING CORRECTIVE TREATMENT WAS UNKNOWN, OUTCOME OF EVENT WAS RECOVERED AND STATUS OF HUMAPEN LUXURA HD WAS UNKNOWN. FOLLOW UP NOT POSSIBLE AS CONSENT TO CONTACT WITH REPORTER AN

  Patient problems: Coma

  MAUDE report 14574350 ↗