NovoPen Echo® 185459Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00301691854591), received between Jan 30, 2017 and Mar 7, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Failure to Deliver” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Fracture; Failure to Deliver; Fracture; Failure to Deliver

  EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) NOT BEING ABLE TO TAKE MEDICATION [DRUG DOSE OMISSION BY DEVICE] PEN BROKE [DEVICE BREAKAGE]. CASE DESCRIPTION: STUDY ID: (B)(6). STUDY DESCRIPTION: THE MAIN OBJECTIVE OF THIS PATIENT SUPPORT PROGRAM IS TO INVESTIGATE THE USE OF COPAY CARD FOR PATIENTS USING NOVOPEN ECHO PEN DEVICE. THIS SERIOUS SOLICITED REPORT FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "NOT BEING ABLE TO TAKE MEDICATION(DRUG DOSE OMISSION BY DEVICE)" WITH AN UNSPECIFIED ONSET DATE , "PEN BROKE(DEVICE BREAKAGE)" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A CHILD FEMALE PATIENT (AGE UNSPECIFIED) WHO WAS TREATED WITH NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", MEDICAL HISTORY WAS NOT PROVIDED. IT WAS REPORTED THAT, THE PATIENT HAD BEEN HOSPITALIZED AS THEIR NOVOPEN ECHO HAD BROKEN LEADING TO THEM NOT BEING ABLE TO TAKE MEDICATION. THE OTHER DETAILS OF THE PATIENT'S HOSPITALIZATION WERE UNSPECIFIED. BATCH NUMBERS OF NOVOPEN ECHO WERE UNAVAILABLE. ACTION TAKEN TO NOVOPEN ECHO WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "NOT BEING ABLE TO TAKE MEDICATION (DRUG DOSE OMISSION BY DEVICE)" WAS

  Patient problems: Insufficient Information

  MAUDE report 21545461 ↗
• InjuryNov 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS), PATIENT'S GLUCOSE METER READ HIGH [BLOOD GLUCOSE INCREASED], PISTON ROD DISLODGED CAUSING ISSUES WITH INJECTION [DEVICE ISSUE], CRACK IN THE NOVOLOG VIAL THAT WAS CAUSING THE ISSUE [PRODUCT PHYSICAL ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "PATIENT'S GLUCOSE METER READ HIGH(BLOOD SUGAR INCREASED)" BEGINNING ON (B)(6) 2022, "PISTON ROD DISLODGED CAUSING ISSUES WITH INJECTION(DEVICE COMPONENT DETACHED)" WITH AN UNSPECIFIED ONSET DATE, "CRACK IN THE NOVOLOG VIAL THAT WAS CAUSING THE ISSUE(CRACKED PRODUCT)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 75 YEARS OLD MALE PATIENT WHO WAS TREATED WITH NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", , NOVOLOG PENFILL (INSULIN ASPART) SOLUTION FOR INJECTION, 100 IU/ML (DOSE, FREQUENCY & ROUTE USED - UNK, SUBCUTANEOUS) FROM UNKNOWN START DATE FOR "TYPE 1 DIABETES MELLITUS", , INSULIN ASPART PENFILL (INSULIN ASPART) SOLUTION FOR INJECTION (DOSE, FREQUENCY & ROUTE USED - UNK, SUBCUTANEOUS) FROM UNKNOWN START DATE FOR "TYPE 1 DIABETES", CURRENT CONDITION: TYPE 1

  Patient problems: Hyperglycemia

  MAUDE report 15852902 ↗
• InjuryFeb 2, 2022Defective Component; Inaccurate Delivery; Defective Component; Inaccurate Delivery

  (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS): BLOOD SUGAR READINGS OF 500 MG/DL [BLOOD GLUCOSE INCREASED]. THE BLACK PART THAT HOLDS INSULIN GOT STUCK IN TOP PART OF CAP OF PEN AND NOW THE PISTON ROD THAT PUSHES INSULIN THROUGH IS NOT WORKING SO THAT THE INSULIN IS NOT CONSISTENT [DEVICE MALFUNCTION]. THE BLACK PART THAT HOLDS INSULIN GOT STUCK IN TOP PART OF CAP OF PEN AND NOW THE PISTON ROD THAT PUSHES INSULIN THROUGH IS NOT WORKING SO THAT THE INSULIN IS NOT CONSISTENT [DEVICE DELIVERY SYSTEM ISSUE]. THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "BLOOD SUGAR READINGS OF 500 MG/DL(BLOOD SUGAR INCREASED)" BEGINNING ON (B)(6) 2021, "THE BLACK PART THAT HOLDS INSULIN GOT STUCK IN TOP PART OF CAP OF PEN AND NOW THE PISTON ROD THAT PUSHES INSULIN THROUGH IS NOT WORKING SO THAT THE INSULIN IS NOT CONSISTENT(DEVICE COMPONENT MALFUNCTION)" WITH AN UNSPECIFIED ONSET DATE, "THE BLACK PART THAT HOLDS INSULIN GOT STUCK IN TOP PART OF CAP OF PEN AND NOW THE PISTON ROD THAT PUSHES INSULIN THROUGH IS NOT WORKING SO THAT THE INSULIN IS NOT CONSISTENT(INACCURATE DELIVERY BY DEVICE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A (B)(6) FEMALE PATIENT WHO WAS

  Patient problems: Hyperglycemia

  MAUDE report 13422726 ↗
• InjuryOct 20, 2021Failure to Deliver; Failure to Deliver

  CASE DESCRIPTION: IN ORDER TO PROTECT THE SAFETY OF PATIENT IT WILL, IN RARE CASES, BE REQUIRED TO DISASSEMBLE THE MEDICAL DEVICE IMMEDIATELY IN A WAY WHERE IT IS NOT SUBSEQUENTLY POSSIBLE TO REASSEMBLE IT (E.G. DESTRUCTIVE TESTING OR ALTERING OF THE MEDICAL DEVICE). THE DISASSEMBLED MEDICAL DEVICE WILL BE STORED WITH THE SAME RETENTION PERIOD AS OTHER COMPLAINT SAMPLES INVESTIGATION RESULT: . SUSPECT PRODUCT: NOVOPEN ECHO BATCH NUMBER: KVG1M781. A VISUAL EXAMINATION OF THE RETURNED PRODUCT WAS PERFORMED. THE ELECTRONIC REGISTER WAS CHECKED. NO REMARKS. VISUAL EXAMINATION AND FUNCTIONAL TESTING WERE PERFORMED. THE DEVICE WAS TESTED WITH A RANDOM CARTRIDGE AND A NOVO NORDISK NEEDLE WAS MOUNTED. DURING TESTING IT WAS POSSIBLE TO DELIVER PREPARATION FROM THE CARTRIDGE. THE DOSE ACCURACY WAS MEASURED BY WEIGHING USING A RANDOM CARTRIDGE. THE PRODUCT WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. DURING EXAMINATION OF THE PRODUCT, NO IRREGULARITIES RELATED TO THE COMPLAINT WERE DETECTED. FINAL MANUFACTURER'S COMMENT: 18-OCT-2021: THE SUSPECTED DEVICE NOVOPEN ECHO WAS RETURNED TO NOVO NORDISK AND INVESTIGATION OF THE DEVICE SHOWED THAT IT WAS WORKING IN ACC

  Patient problems: Hyperglycemia

  MAUDE report 12666199 ↗
• InjuryApr 8, 2021Failure to Deliver; Failure to Deliver

  LOW BLOOD SUGARS [BLOOD GLUCOSE DECREASED]. HIGH BLOOD SUGARS [BLOOD GLUCOSE INCREASED]. NOVOPEN ECHO WOULD NOT DEPRESS MEDICATION [DEVICE FAILURE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "LOW BLOOD SUGARS(BLOOD SUGAR DECREASED)" BEGINNING ON (B)(6) 2021, "HIGH BLOOD SUGARS(BLOOD SUGAR INCREASED)" BEGINNING ON (B)(6) 2021, "NOVOPEN ECHO WOULD NOT DEPRESS MEDICATION(DEVICE FAILURE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A (B)(6) FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT PRODUCTS INCLUDED - NOVOLOG PENFILL(INSULIN ASPART) SOLUTION FOR INJECTION, 100 U/ML, LEVEMIR(INSULIN DETEMIR) SOLUTION FOR INJECTION, .0024 MOL/L TREATMENT INCLUDED - GLUCAGEN HYPOKIT(GLUCAGON). ON AN UNKNOWN DATE NOVOPEN ECHO DID NOT DEPRESS MEDICATION. IT WAS REPORTED THAT THE BACKUP PEN ALSO DID NOT DEPRESS THE MEDICATION EITHER. DUE TO BOTH OF THE PENS NOT ADMINISTERING, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM ON (B)(6) 2021 DUE TO B

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 11633846 ↗
• InjuryMar 17, 2021Defective Device; Defective Device

  CASE DESCRIPTION: INVESTIGATION RESULT: NAME: NOVOPEN ECHO - BATCH KVG0M24-3 THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. NAME: NOVOLOG PENFILL 3 ML CARTRIDGES 100 UNITS/ML (U-100) - BATCH KS6CA00 THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. A REFERENCE SAMPLE WAS EXAMINED MACROSCOPICALLY AND ANALYSED CHEMICALLY. THE REFERENCE SAMPLE WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. DURING INVESTIGATION NO IRREGULARITIES RELATED TO THE COMPLAINT WAS DETECTED ON A REFERENCE/RESERVE SAMPLE OF THE BATCH IN QUESTION. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: -INVESTIGATION RESULTS UPDATED. -IMDRF CODES (B, C, D AND G) WERE UPDATED. -NARRATIVE UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: (B)(6) 2021: THE SUSPECTED DEVICE (NOVOPEN ECHO) HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR THE INVESTIGATION. THE BATCH TREND ANALYSIS AND REFERENCE SAMPLE EXAMINATION REVEALED NOTHING ABNORMAL. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. WITH THE AVAILABLE

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 11507338 ↗
• InjuryFeb 9, 2021Failure to Deliver; Failure to Deliver

  CASE DESCRIPTION: INVESTIGATIONAL RESULT: NAME: NOVOPEN ECHO ; BATCH :UNKNOWN. NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. INVESTIGATIONAL RESULTS: NAME: NOVOLOG PENFILL 3 ML CARTRIDGES 100 UNITS/ML (U-100) . BATCH JS69H79. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. A REFERENCE SAMPLE CHECK WAS FOUND TO BE OK. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: INVESTIGATIONAL RESULTS UPDATED. B,C,D AND G CODED UPDATED. NARRATIVE UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: 05-MAR-2021: THE SUSPECTED DEVICE (NOVOPEN ECHO) HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR THE INVESTIGATION. THE BATCH NUMBER WAS FOUND TO BE IN-VALID. NO BATCH TREND ANALYSIS OR REFERENCE SAMPLE EXAMINATION PERFORMED. WITH THE AVAILABLE LIMITED INFORMATION, IT IS THEREFORE NOT POSSIBLE TO IDENTIFY A CLEAR ROOT CAUSE IN RELATION TO THE FUNCTIONALITY OF NOVOPEN ECHO. HOWEVER, YOUNG AGE OF THE PATIENT WITH UNDERLYING DIABETES MELLITUS IS A SIGNIFICANT CONFOUNDING FACTOR FOR THE DEVELOPMENT OF DIABETIC KETOACIDOSIS. H3

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 11300689 ↗
• InjuryJun 3, 2020Break; Break

  CASE DESCRIPTION: INVESTIGATION RESULTS: NAME: NOVOPEN ECHO, BATCH NUMBER: FVGA926-2. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE BATCH DOCUMENTATION WAS REVIEWED AND FOUND TO BE NORMAL. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. NAME: NOVOPEN ECHO - BATCH EVG1226-3. A VISUAL EXAMINATION OF THE RETURNED PRODUCT WAS PERFORMED. THE ELECTRONIC REGISTER WAS CHECKED. MITIGATION CODES INDICATING USE OF A BROKEN NEEDLE WERE PRESENT. VISUAL EXAMINATION AND FUNCTIONAL TESTING WERE PERFORMED. ONE SNAP CRACKED AND ONE SNAP BROKEN OFF THE CARTRIDGE HOLDER. DOSE ACCURACY WAS NOT PERFORMED AS CARTRIDGE HOLDER IS BROKEN TO AN EXTENT WHERE IT DOES NOT MAKE SENSE TO PERFORM THE TEST DURING DEVELOPMENT OF THE FAULT ON THE CARTRIDGE HOLDER STARTING WITH A CRACK AND TO THE STATE THAT THE CARTRIDGE HOLDER WAS IN DURING OUR EXAMINATION, IT CANNOT BE RULED OUT THAT THE DOSAGE ACCURACY WAS AFFECTED AT A TIME DURING USE. IF THE PATIENT DOES NOT OBSERVE THAT THE CARTRIDGE HOLDER IS DAMAGED THERE IS A RISK THAT HE/SHE WILL NOT RECEIVE THE INTENDED DOSE AND EXPERIENCE HYPERGLYCAEMIA. CONFIRMED THE SNAP CONNECTION ON THE CARTRIDGE HOLDER IS DAMAGED. AS A CONSEQUENCE, THE CARTRIDGE HOLD

  Patient problems: Hyperglycemia

  MAUDE report 10116722 ↗
• InjuryApr 17, 2020Failure to Deliver; Failure to Deliver

  EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). HIGH BLOOD SUGARS DUE TO PEN NOT DELIVERING [BLOOD GLUCOSE INCREASED]. PEN NOT DELIVERING [DEVICE FAILURE]. EAR INFECTION [EAR INFECTION]. FEVER [PYREXIA]. TONSILLITIS [TONSILLITIS]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "HIGH BLOOD SUGARS DUE TO PEN NOT DELIVERING (BLOOD SUGAR INCREASED)" BEGINNING ON (B)(6) 2018, "PEN NOT DELIVERING(DEVICE FAILURE)" BEGINNING ON (B)(6) 2018, "EAR INFECTION (EAR INFECTION)" BEGINNING ON (B)(6) 2018, "FEVER (FEVER)" BEGINNING ON (B)(6) 2018, "TONSILLITIS(TONSILLITIS)" BEGINNING ON (B)(6) 2018, AND CONCERNED A (B)(6) OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM (B)(6) 2018 AND ONGOING FOR "TYPE 1 DIABETES MELLITUS", NOVOLOG PENFILL (INSULIN ASPART) (SOLUTION FOR INJECTION, 100 U/ML) (DOSE, FREQUENCY & ROUTE USED - UNK, SUBCUTANEOUS) FROM UNKNOWN START DATE FOR "TYPE 1 DIABETES MELLITUS". CURRENT CONDITION: TYPE 1 DIABETES MELLITUS (DURATION NOT REPORTED). TREATMENT INCLUDED - AMOXICILLIN. THE REPORTER MOTHER OF THE PATIENT REPORTED THAT HER (B)(6) YEAR OLD DAUGHTER HAS BE

  Patient problems: Hyperglycemia

  MAUDE report 9974667 ↗
• InjuryMar 13, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS), BLOOD SUGAR OVER 400-500 MG/DL [BLOOD GLUCOSE INCREASED], PEN NEEDING TO BE PRIMED UP TO 5 TIMES BEFORE ANY INSULIN COMES OUT OF THE PEN [DEVICE DIFFICULT TO USE], BLOOD SUGARS NOT ABLE TO GET UNDER 400-500 MG/DL DUE TO PARTICULAR BATCH [PRODUCT QUALITY ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE (B)(6) WAS REPORTED BY A CONSUMER AS "BLOOD SUGAR OVER 400-500 MG/DL(BLOOD GLUCOSE INCREASED)" BEGINNING ON (B)(6) 2020, "PEN NEEDING TO BE PRIMED UP TO 5 TIMES BEFORE ANY INSULIN COMES OUT OF THE PEN(DEVICE DIFFICULT TO USE)" BEGINNING ON (B)(6) 2020, "BLOOD SUGARS NOT ABLE TO GET UNDER 400-500 MG/DL DUE TO PARTICULAR BATCH(PRODUCT LOT SPECIFIC ISSUE)" BEGINNING ON (B)(6) 2020, AND CONCERNED A (B)(6) FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "TYPE 1 DIABETES MELLITUS", NOVOLOG PENFILL (INSULIN ASPART) FROM (B)(6) 2020 AND ONGOING FOR "TYPE 1 DIABETES MELLITUS" (DOSE AND FREQUENCY SLIDING SCALE). THE PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX (BMI): NOT REPORTED. DOSAGE REGIMENS: NOVOPEN ECHO: NOVOLOG PENFILL: (B)(6) 2020 TO NOT REPORTED (DOSAGE REGIMEN ONGOING

  Patient problems: Hyperglycemia

  MAUDE report 9828718 ↗
• InjuryDec 3, 2019Mechanical Jam; Mechanical Jam

  CASE DESCRIPTION: INVESTIGATION RESULT: NAME: NOVOPEN ECHO - BATCH FVG7149-1. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NAME: NOVOPEN ECHO - BATCH EV40014. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NAME: NOVOPEN ECHO - BATCH HVGL387-1. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: INVESTIGATION RESULTS WERE UPDATED. MANUFACTURER COMMENT WAS UPDATED. NARRATIVE UPDATED ACCORDINGLY. MANUFACTURER COMMENT: 21-JAN-2020: AS THE DEVICE (NOVOPEN ECHO BATCH NO. FVG7149-1, EV40014 AND HVGL387-1) HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR INVESTIGATION AND ONLY VERY LIMITED INFORMATION REGARDING THE HANDLING OF SUSPECTED DEVICE IS AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT-CAUSE OF THE EXPERIENCED ADVERSE EVENT AND THUS FIND SIMILAR INCIDENTS TO THE ONE REPORTED IN ARGUS CASE (B)(4)

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9404091 ↗
• InjuryOct 10, 2019Break; Break

  CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "HOSPITALIZATION (HOSPITALIZATION)" BEGINNING ON (B)(6) 2019, "PISTON ROD WAS BROKEN AT THE TOP OF THE PEN (DEVICE BREAKAGE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 9 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY". MEDICAL HISTORY WAS NOT PROVIDED. PATIENT WAS USING HUMALOG WITH NOVOPEN ECHO. ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED PRIOR TO USE OF NOVOPEN ECHO. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND JUVENILE TYPE 1 DIABETES WHICH ARE STILL ONGOING. ON (B)(6) 2019, THE CAREGIVER CLARIFIED THAT PATIENT'S NOVOPEN ECHO HAD A BROKEN PISTON AND NO MEDICATION WOULD DISPENSE OUT OF THE PEN DURING PRIMING. AS A RESULT HAD EMERGENCY INSULIN CALLED IN AS THEY DID NOT GET THEIR SCHEDULED DOSE. BATCH NUMBERS: NOVOPEN ECHO: HVGM563-2. THE OUTCOME FOR THE EVENT "HOSPITALIZATION (HOSPITALIZATION)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "PISTON ROD WAS BROKEN AT THE TOP OF THE PEN (DEVICE BREAKAGE)" WAS NOT REPORTED. INVESTIGATION RESULTS: NAME: NOVOPEN ECHO, BATCH NUMBER: HV

  Patient problems: No Code Available

  MAUDE report 9174513 ↗
• InjuryMar 7, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). HEART RATE DROPPED TO 36 BEATS PER MINUTE [HEART RATE DECREASED]. IRREGULAR HEART BEAT [HEART RATE IRREGULAR]. SWELLING IN LEGS [PERIPHERAL SWELLING]. SWELLING IN FEET [PERIPHERAL SWELLING]. GLYCOSYLATED HEMOGLOBIN LEVELS WERE CONSISTENTLY 9% [GLYCOSYLATED HAEMOGLOBIN INCREASED]. DIFFICULTY CONTROLLING BLOOD GLUCOSE [DIABETES MELLITUS INADEQUATE CONTROL]. DIFFICULTY CONCENTRATING [DISTURBANCE IN ATTENTION]. PRODUCTS UNDER DELIVERED INSULIN [INCORRECT DOSE ADMINISTERED BY DEVICE]. PRODUCTS MALFUNCTIONED [DEVICE MALFUNCTION]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS REGULATORY AUTHORITY CASE FROM THE UNITED STATES RECEIVED VIA FDA (US FOOD AND DRUG ADMINISTRATION), USA WAS REPORTED BY A CONSUMER AS "HEART RATE DROPPED TO 36 BEATS PER MINUTE" BEGINNING ON 2017 (BEFORE (B)(6) 2017) , "IRREGULAR HEART BEAT" BEGINNING ON (B)(6) 2017, "SWELLING IN LEGS" BEGINNING ON 2016, "SWELLING IN FEET" BEGINNING ON 2016, "GLYCOSYLATED HEMOGLOBIN LEVELS WERE CONSISTENTLY 9%" BEGINNING ON (B)(6) 2016, "DIFFICULTY CONTROLLING BLOOD GLUCOSE" BEGINNING ON (B)(6) 2016, "DIFFICULTY CONCENTRATING" BEGINNING ON (B)(6) 2016, "PROD

  Patient problems: Arrhythmia; Bradycardia; Cognitive Changes; Hyperglycemia; No Code Available; Swelling

  MAUDE report 7321158 ↗
• InjuryNov 14, 2017Device Operates Differently Than Expected; Infusion or Flow Problem; Device Operates Differently Than Expected; Infusion or Flow Problem

  CASE DESCRIPTION: INVESTIGATION RESULT: NAME: NOVOPEN¿ ECHO¿, BATCH NUMBER: FVGA926-1 THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE COMPLAINT HAS BEEN REGISTERED IN THE NOVO NORDISK COMPLAINT HANDLING SYSTEM. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED. NOTHING ABNORMAL WAS FOUND. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: INVESTIGATION RESULT ADDED. COMPANY/MANUFACTURER'S COMMENT ADDED NARRATIVE UPDATED ACCORDINGLY. COMPANY/MANUFACTURER'S COMMENT: 15-NOV-2017: AS THE DEVICE NOVOPEN ECHO HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR INVESTIGATION AND ONLY VERY LIMITED INFORMATION REGARDING THE HANDLING OF SUSPECTED DEVICE IS AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT-CAUSE OF THE EXPERIENCED ADVERSE EVENT AND THUS FIND SIMILAR INCIDENTS TO THE ONE REPORTED IN (B)(4). EVALUATION SUMMARY: NOVOPEN ECHO, BATCH NUMBER: FVGA926-1 THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED. NOTHING ABNORMAL WAS FOUND.

  Patient problems: Hyperglycemia

  MAUDE report 7029450 ↗
• InjuryJan 30, 2017Failure to Deliver; Failure to Deliver

  INFECTION. ACUTE DIABETIC KETOSIS COMPLICATED BY AN INFECTION. ECHO PEN NOT DELIVERING HIS MEDICATION (POSSIBLY A CALIBRATION ISSUE). [DEVICE ISSUE]. I WAS ON VACATION AND DO NOT KNOW IF THE INSULIN WAS STORED CORRECTLY. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A GENERAL PHYSICIAN AS "ACUTE DIABETIC KETOSIS ", " INFECTION", "NOVOECHO PEN DID NOT DELIVER INSULIN, MAYBE THE CALIBRATION STOPPED WORKING", "I WAS ON VACATION AND DO NOT KNOW IF THE INSULIN WAS STORED CORRECTLY" ALL BEGINNING ON (B)(6) 2016, AND CONCERNED A (B)(6) MALE PATIENT WHO WAS TREATED WITH LEVEMIR (INSULIN DETEMIR) FROM 2014 AND ONGOING DUE TO "TYPE 1 DIABETES MELLITUS", NOVOLOG PENFILL (FAST ACTING INSULIN ASPART) FROM UNKNOWN START DATE AND ONGOING DUE TO "TYPE 1 DIABETES MELLITUS" AND NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE DUE TO "TYPE 1 DIABETES MELLITUS". PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX (BMI) WERE NOT REPORTED. MEDICAL HISTORY INCLUDED TYPE 1 DIABETES MELLITUS (DURATION NOT REPORTED). TREATMENT DRUGS INCLUDED DEXTROSE (GLUCOSE) AND SALINE (SODIUM CHLORIDE). IT WAS REPORTED THAT THE PATIENT WAS ON VACATION DURING END OF(B)(6) 20

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Unspecified Infection

  MAUDE report 6286082 ↗