HumaPen® Luxura™ HD - SAMPLE MS9675Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00300029675013), received between May 1, 2018 and Feb 3, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2021Inaccurate Delivery

  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 A PRODUCT COMPLAINT (PC), CONCERNED A (B)(6) YEAR-OLD FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY INCLUDED TYPE 1 DIABETES WHEN SHE WAS (B)(6) YEARS OLD. CONCOMITANT MEDICATIONS INCLUDED INSULIN ASPART, INSULIN GLARGINE AND INSULIN DEGLUDEC; ALL FOR DIABETES. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG, 100U/ML) VIA CARTRIDGE VIA REUSABLE PEN (HUMAPEN LUXURA HD) AT AN UNKNOWN DOSE AND FREQUENCY SUBCUTANEOUSLY FOR THE TREATMENT OF DIABETES, BEGINNING APPROXIMATELY ON AN UNKNOWN DATE IN 1992. ON AN UNKNOWN DATE, WHILE ON INSULIN LIPRO THERAPY, SHE WAS DIAGNOSED WITH THYROID EYE DISEASE, BUT SHE COULD SEE JUST FINE. IN 1997, SHE UNDERWENT RADIATION AND WAS TREATED WITH METHIAMAZOLE. IN 2015 METHIMAZOLE WAS DISCONTINUED AS RECOMMENDED BY HER ENDOCRINOLOGIST AND SHE EXPERIENCED THYROID EYE DISEASE AS EYES BULDING OUT, BLURRY VISION AND LOST WEIGHT. SHE SWITCHED TO A NEW ENDOCRINOLOGIST. IN (B)(6) 2016 SHE UNDERWENT THYROID REMOVAL AND WAS PUT ON LEVOTHYROXINE. SHE UNDERWENT FO

  Patient problems: Hyperglycemia; Myocardial Infarction

  MAUDE report 11274105 ↗
• InjuryFeb 6, 2019Break

  LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLIANT: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS AND PRODUCT COMPLIANT (PC), CONCERNED A 55-YEARS-OLD FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY INCLUDED BRITTLE DIABETES. CONCOMITANT MEDICATION INCLUDED INSULIN GLARGINE FOR TYPE 1 DIABETES. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG 100U/ML) FROM A VIAL VIA AN UNKNOWN DEVICE, SUBCUTANEOUSLY, FOR TREATMENT OF TYPE 1 DIABETES, BEGINNING ON AN UNKNOWN DATE. DOSAGE REGIMEN WAS NOT PROVIDED. SHE ALSO RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG 100U/ML) FROM CARTRIDGE VIA A REUSABLE HUMAPEN LUXURA HALF-DOSE (HD) DEVICE, AT AN UNKNOWN DOSE ON SLIDING SCALE, SUBCUTANEOUSLY, FOR TREATMENT OF TYPE 1 DIABETES, BEGINNING ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, AFTER STARTING INSULIN LISPRO THERAPY, HER HUMAPEN LUXURA HALF-DOSE DEVICE WAS BROKEN AND SHE WAS NOT RECEIVING INSULIN (PC (B)(4) /LOT 0705G01). SHE STARTED TAKING INSULIN SYRINGES AND DRAWING THE INSULIN OUT OF THE CARTRIDGES. HER BLOOD SUGARS WERE GETTING AS HIGH AS 416 AND 500 (NO UNITS AND REFERENCE RANGES W

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8311258 ↗
• InjuryMay 1, 2018Failure to Deliver

  LILLY CASE ID: (B)(6). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLIANT: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS AND A PRODUCT COMPLAINT (PC), CONCERNED A (B)(6)-YEAR-OLD FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY INCLUDED DIABETES DIAGNOSED IN 1975. CONCOMITANT MEDICATION INCLUDED INSULIN DETEMIR FOR THE TREATMENT OF TYPE I DIABETES. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG) VIA REUSABLE PEN (HUMAPEN LUXURA HD), 12 UNITS FOR THE TREATMENT OF TYPE I DIABETES. FREQUENCY, ROUTE OF ADMINISTRATION AND START THERAPY DATE WERE NOT PROVIDED. ON (B)(6) 2018 WHEN SHE ATTEMPTED TO TAKE 12 UNITS OF INSULIN LISPRO WITH HER LUXURA HD PEN, SHE DID NOT BELIEVE SHE RECEIVED ANY INSULIN FROM THE INJECTION; AS A RESULT OF THIS MISSED DOSE HER BLOOD SUGAR WAS OVER 500 (NO UNITS PROVIDED) FOR MOST OF THE DAY. SHE FELT LIGHT HEADED AND SHAKY, SO SHE CALLED HER HEALTH CARE PROFESSIONAL (HCP) AND WAS ADVISED TO TAKE 3 UNITS EVER THREE HOURS UNTIL SHE GOT HER SUGAR DOWN TO 300 (NO UNITS PROVIDED) AND THEN SHE COULD EAT AND GO BACK TO HER REGULAR DOSE SCHEDULE. SHE FOLLOWED THIS INSTRUCTION BUT HER SUGAR LE

  Patient problems: Dizziness; High Blood Pressure/ Hypertension; Hyperglycemia; Shaking/Tremors

  MAUDE report 7477584 ↗