BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN

    MDR report key: 19699568 · Received July 9, 2024

    Report

    Report Number
    9681821-2024-00118
    Event Type
    Injury
    Date Received
    July 9, 2024
    Report Date
    June 18, 2024
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMF
    PMA / PMN Number
    K861686
    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 RESULT: SUSPECT- NOVOPEN, BATCH NUMBER- UNKNOWN NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. SINCE LAST SUBMISSION THE CASE HAVE BEEN UPDATED WITH THE FOLLOWING: QC RESULT ANS QC COMMENT FIELD UPDATED. EXPECTED DATE OF FU UPDATED. ADDITIONAL INFORMATION BOX TICKED. ANNEX B,C,D,G CODES UPDATED. NARRATIVE UPDATED ACCORDINGLY. NO FURTHER INFORMATION AVAILABLE. FINAL MANUFACTURER'S COMMENT: (B)(6) 2024: THE SPECIFIC NAME OF THE DEVICE IS UNKNOWN. THE SUSPECTED DEVICE 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. THE CASE IS CONSIDERED AS NON-REPORTABLE SINCE WE DO NOT KNOW THE SPECIFIC NAME OF DEVICE AND BATCH NUMBER OF THE DEVICE UNKNOWN. H3 CONTINUED: EVALUATION SUMMARY SUSPECT- NOVOPEN, BATCH NO-UNKNOWN: NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE.

    Description of Event or Problem · 0

    EVENT [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) DIZZINESS [DIZZINESS] THE NOVOPEN WAS BROKEN [DEVICE BREAKAGE] CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM CHINA WAS REPORTED BY A CONSUMER AS "DIZZINESS(DIZZINESS)" WITH AN UNSPECIFIED ONSET DATE, "THE NOVOPEN WAS BROKEN(DEVICE BREAKAGE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "TYPE 2 DIABETES MELLITUS", PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX WERE NOT RPORTED DOSAGE REGIMENS: NOVOPEN: CURRENT CONDITION: TYPE 2 DIABETES MELLITUS (DURATION WAS NOT REPORTED). PATIENT'S RELATIVE REPORTED THAT THE NOVOPEN WAS BROKEN. THE NOVOPEN WAS OLD. THE PEN WAS IN THE HOSPITAL. THE PATIENT'S RELATIVE COULD NOT PROVIDE THE MODEL OR BATCH NUMBER OF THE PEN, OR CLEARLY DESCRIBED THE PROBLEM OF THE PEN. ON AN UNKNOWN DATE PATIENT WAS HOSPITALIZED (DETAILS OF HOSPITALIZATION WAS NOT REPORTED) DUE TO DIZZINESS. BATCH NUMBER FOR NOVOPEN WAS UNKNOWN ACTION TAKEN TO NOVOPEN WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "DIZZINESS(DIZZINESS)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "THE NOVOPEN WAS BROKEN(DEVICE BREAKAGE)" WAS NOT REPORTED. THE EVENT ONSET DATE IS NOT REPORTED IN THE CASE. HOWEVER, THE INCIDENT DATES ARE CAPTURED TO ENSURE THE MIR FORM IS GENERATED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249929 NOVOPEN INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization