BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 19789481 · Received July 22, 2024

    Report

    Report Number
    9681821-2024-00126
    Event Type
    Injury
    Date Received
    July 22, 2024
    Report Date
    July 1, 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 FOLLOWING WERE UPDATED: -FINAL REPORT WAS TICKED, EXPECTED DATE OF FOLLOW UP REPORT WAS REMOVED AND FOLLOW UP INFORMATION - FURTHER INVESTIGATION UPDATED IN EU/CA TAB. -IMDRF CODES UPDATED IN DEVICE ADDENDUM TAB. -IS NON-REPORTABLE UPDATED. -INVESTIGATIONAL RESULTS UPDATED. -NARRATIVE UPDATED ACCORDINGLY. NO FURTHER INFORMATION AVAILABLE. FINAL MANUFACTURER'S COMMENT: (B)(6) 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 CONDITION OF TYPE 2 DIABETES MELLITUS IS A SIGNIFICANT CONFOUNDING FACTOR FOR REPORTED HYPERGLYCAEMIA. H3 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); PRE-PRANDIAL BLOOD GLUCOSE WAS 18 (MMOL/L) [BLOOD GLUCOSE INCREASED], NOVOPEN 4 COULD NOT BE PUSHED. (PISTON ROD LEANED AGAINST THE RUBBER PLUNGER OF THE MEDICATION LIQUID) [DEVICE MECHANICAL ISSUE] CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM CHINA WAS REPORTED BY A CONSUMER AS "PRE-PRANDIAL BLOOD GLUCOSE WAS 18 (MMOL/L)(BLOOD GLUCOSE INCREASED)" WITH AN UNSPECIFIED ONSET DATE, "NOVOPEN 4 COULD NOT BE PUSHED (PISTON ROD LEANED AGAINST THE RUBBER PLUNGER OF THE MEDICATION LIQUID)(DEVICE MECHANICAL JAM)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 51 YEARS OLD MALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "TYPE 2 DIABETES MELLITUS", PATIENT'S HEIGHT: 170 CM. PATIENT'S WEIGHT: 70 KG. PATIENT'S BMI: 24.22145330. DOSAGE REGIMENS: NOVOPEN 4: CURRENT CONDITION: TYPE 2 DIABETES MELLITUS (FOR 10 YEARS). SINCE AN UNKOWN DATE NOVOPEN 4 COULD NOT BE PUSHED. THE PATIENT COOPERATED WITH THE HOTLINE TO HANDLE THE PRODUCT. THE PATIENT REPEATEDLY PERFORMED PUSHING, AND THE PISTON ROD LEANED AGAINST THE RUBBER PLUNGER OF THE MEDICATION LIQUID. AFTER THE NEEDLE (BRAND UNKNOWN) WAS INSTALLED, THE MEDICATION CAME OUT. ON AN UNKNOWN DATE THE PATIENT WAS HOSPITALIZED (DETAILS UNAVAILABLE) BECAUSE PRE-PRANDIAL BLOOD GLUCOSE (BLOOD GLUCOSE)WAS 18 MMOL/L. BATCH NUMBERS: NOVOPEN 4: NOT AVAILABLE. ACTION TAKEN TO NOVOPEN 4 WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "PRE-PRANDIAL BLOOD GLUCOSE WAS 18 (MMOL/L)(BLOOD GLUCOSE INCREASED)" WAS NOT REPORTED. ON (B)(6) 2024 THE OUTCOME FOR THE EVENT "NOVOPEN 4 COULD NOT BE PUSHED (PISTON ROD LEANED AGAINST THE RUBBER PLUNGER OF THE MEDICATION LIQUID)(DEVICE MECHANICAL JAM)" WAS RECOVERED. NO FURTHER INFOMRATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733223 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other| H