BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 20449672 · Received October 15, 2024

    Report

    Report Number
    9681821-2024-00159
    Event Type
    Injury
    Date Received
    October 15, 2024
    Report Date
    September 19, 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: SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: -EXPECTED DATE OF FOLLOW UP REPORT EXTENDED -NARRATIVE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS), CEREBRAL INFARCTION [CEREBRAL INFARCTION], THE BLOOD GLUCOSE WAS 22 MMOL/L [BLOOD GLUCOSE INCREASED], THE DOSE ADJUSTMENT KEY STUCK AND COULD NOT BE USED. [DEVICE MALFUNCTION]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM CHINA WAS REPORTED BY A CONSUMER AS "CEREBRAL INFARCTION (CEREBRAL INFARCTION)" WITH AN UNSPECIFIED ONSET DATE, "THE BLOOD GLUCOSE WAS 22 MMOL/L(BLOOD GLUCOSE INCREASED)" WITH AN UNSPECIFIED ONSET DATE, "THE DOSE ADJUSTMENT KEY STUCK AND COULD NOT BE USED.(DEVICE COMPONENT MALFUNCTION)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", THE PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX WERE NOT REPORTED. MEDICAL HISTORY WAS NOT PROVIDED. SINCE AN UNKNOWN DATE PATIENT'S NOVOPEN 4 WAS UNABLE TO ADJUST THE DOSE, THE DOSE ADJUSTMENT KEY STUCK AND COULD NOT BE USED, REQUIRING AFTER-SALES. THE BOX WAS DISCARDED AND THE DOSE KEY COULD NOT BE ADJUSTED SO THE LOT NUMBER COULD NOT BE PROVIDED. ON AN UNKNOWN DATE THE PATIENT CAME TO THE HOSPITAL (DETAILS NOT REPORTED) DUE TO CEREBRAL INFARCTION, THE BLOOD GLUCOSE (BLOOD GLUCOSE) WAS 22 MMOL/L BECAUSE THE INSULIN WAS NOT INJECTED. BATCH NUMBERS: NOVOPEN 4: YUG0587. ACTION TAKEN TO NOVOPEN 4 WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "CEREBRAL INFARCTION (CEREBRAL INFARCTION)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "THE BLOOD GLUCOSE WAS 22 MMOL/L (BLOOD GLUCOSE INCREASED)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "THE DOSE ADJUSTMENT KEY STUCK AND COULD NOT BE USED (DEVICE COMPONENT MALFUNCTION)" WAS NOT REPORTED. NO FURTHER INFORMATION AVAILABLE. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: PRODUCT TAB UPDATED (BATCH NUMER), NARRATIVE UPDATED ACCORDINGLY. PRELIMINARY MANUFACTURER'S COMMENT: 24-SEP-2024: THE SUSPECTED DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. NO CONCLUSION REACHED. PATIENT WAS ADMITTED WITH CEREBRAL INFARCTION, FOUND TO HAVE HYPERGLYCAEMIA AND DEVICE ISSUE. REFERENCES INCLUDED: REFERENCE TYPE: E2B COMPANY NUMBER REFERENCE ID#: (B)(4). REFERENCE NOTES:

    Description of Event or Problem · 0

    CASE DESCRIPTION: INVESTIGATION RESULTS: NAME: NOVOPEN 4, BATCH NUMBER: YUG0587. THE NUMBER OF COMPLAINTS ON THE BATCH WAS EVALUATED AND, WHEN APPLICABLE, RELEVANT ACTIONS WERE TAKEN. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE NC/DV WERE REVIEWED. BATCH RECORD CONTAINS 3 NONCONFORMITIES, 3 NONCONFORMITIES (NC158681, NC158641, NC155662) NOT RELATED TO ERROR OF "COMPONENT: DEVICE WINDOW".NO IRREGULARITIES RECORDED AND THEREFORE NO FURTHER ACTION. THE BATCH DOCUMENTATION HAS BEEN DESTROYED, BECAUSE IT IS EXCEED ARCHIVED PERIOD. IT IS NOT POSSIBLE TO PERFORM A BATCH REVIEW AS THE BATCH DOCUMENTATION IS NO LONGER AVAILABLE. NO FURTHER INFORMATION AVAILABLE. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: DEVICE TAB: IS NON-REPORTABLE, ROOT CAUSE CONFIRMED AND MALFUNCTION FIELDS UPDATED TO NO-INVESTIGATION RESULTS ADDED, EU/CA TAB: FINAL REPORT CHECK BOX TICKED, EXPECTED DATE OF FOLLOW UP REPORT REMOVED DEVICE ADDENDUM: ANNEX B C D G CODES ADDED NARRATIVE UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: 06-DEC-2024: THE SUSPECTED DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND IN THE REFERENCE SAMPLE ANALYSIS. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. 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. WITH THE AVAILABLE LIMITED INFOMATION, CAUSALITY WITH NOVOPEN 4 FOR CEREBRAL INFARCTION, IS ASSESSED AS UNLIKELY RELATED. H3 CONTINUED: EVALUATION SUMMARY NAME: NOVOPEN 4, BATCH NUMBER: YUG0587 THE NUMBER OF COMPLAINTS ON THE BATCH WAS EVALUATED AND, WHEN APPLICABLE, RELEVANT ACTIONS WERE TAKEN. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE NC/DV WERE REVIEWED. BATCH RECORD CONTAINS 3 NONCONFORMITIES, 3 NONCONFORMITIES (NC158681, NC158641, NC155662) NOT RELATED TO ERROR OF "COMPONENT: DEVICE WINDOW".NO IRREGULARITIES RECORDED AND THEREFORE NO FURTHER ACTION. THE BATCH DOCUMENTATION HAS BEEN DESTROYED, BECAUSE IT IS EXCEED ARCHIVED PERIOD. IT IS NOT POSSIBLE TO PERFORM A BATCH REVIEW AS THE BATCH DOCUMENTATION IS NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36842 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A YUG0587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O