BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 19230076 · Received May 2, 2024

    Report

    Report Number
    9681821-2024-00085
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 20, 2024
    Report Date
    April 20, 2024
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    20-986
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CASE DESCRIPTION: INVESTIGATIONAL RESULTS: NOVOPEN 4: BATCH NUMBER:UNKNOWN NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: INVESITIGATIONAL RESULTS WERE UPDATED. RELEVANT FIELDS UPDATED IN EU/CA TAB AND DEVICE ADDENDUM TAB. IMDRF CODINGS WERE UPDATED NARRATIVE UPDATED ACCORDINGLY. NO FURTHER INFORMATION AVAILABLE FINAL MANUFACTURER'S COMMENT: 14-JUN-2024: THE SUSPECTED DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. BATCH NUMBER OF THE DEVICE UNAVAILABLE DESPITE REPEATED EFFORTS TO FIND THE SAME. NO BATCH TREND ANALYSIS OR REFERENCE SAMPLE ANALYSIS PERFORMED. NO OTHER CONFOUNDING FACTORS IDENTIFIED. WITH THE AVAILABLE LIMITED INFORMATION REGARDING THE HANDLING OF THE SUSPECTED DEVICE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT CAUSE IN RELATION TO FUNCTIONALITY OF NOVOPEN 4. PATIENT'S UNDERLYING MEDICAL HISTORY OF TYPE 2 DIABETES MELLITUS IS A SIGNIFICANT CONFOUNDING FACTOR FOR THE DEVELOPMENT OF HYPERGLYCAEMIA. CONTINUED: EVALUATION SUMMARY NOVOPEN 4: BATCH NUMBER:UNKNOWN NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). THE FASTING BLOOD GLUCOSE WAS 30 (MMOL/L) [BLOOD GLUCOSE INCREASED] MEDICATION LIQUID WAS NOT INJECTED INTO THE BODY WITH THE PEN [DEVICE DELIVERY SYSTEM ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM CHINA WAS REPORTED BY A CONSUMER AS "THE FASTING BLOOD GLUCOSE WAS 30 (MMOL/L)(FASTING BLOOD GLUCOSE INCREASED)" BEGINNING ON (B)(6)2024, "MEDICATION LIQUID WAS NOT INJECTED INTO THE BODY WITH THE PEN(DEVICE DELIVERY SYSTEM ISSUE)" BEGINNING ON (B)(6) 2024, AND CONCERNED A MALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM (B)(6) 2024 FOR "TYPE 2 DIABETES MELLITUS", PATIENT'S HEIGHT: 175 CM. PATIENT'S WEIGHT: 80 KG. PATIENT'S BMI: 26.122449. DOSAGE REGIMENS: NOVOPEN 4: 05-APR-2024 TO NOT REPORTED; CURRENT CONDITION: TYPE 2 DIABETES MELLITUS. CURRENT CONDITION: TYPE 2 DIABETES MELLITUS. (DURATION NOT REPORTED). ON (B)(6) 2024, THE PATIENT'S FASTING BLOOD GLUCOSE (FASTING BLOOD GLUCOSE) WAS 30 MMOL/L., IT WAS SUSPECTED THAT THE MEDICATION LIQUID WAS NOT INJECTED INTO THE BODY WITH THE PEN. BATCH NUMBER OF NOVOPEN 4 WAS REQUESTED AND UNOBTAINABLE. ACTION TAKEN TO NOVOPEN 4 WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "THE FASTING BLOOD GLUCOSE WAS 30 (MMOL/L).(FASTING BLOOD GLUCOSE INCREASED)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "IT WAS SUSPECTED THAT THE MEDICATION LIQUID WAS NOT INJECTED INTO THE BODY WITH THE PEN(DEVICE DELIVERY SYSTEM ISSUE)" WAS NOT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840754 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other