BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 16782860 · Received April 21, 2023

    Report

    Report Number
    9681821-2023-00058
    Event Type
    Injury
    Date Received
    April 21, 2023
    Report Date
    April 9, 2023
    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
    EG
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) HAD ACETONE IN HIS BLOOD [BLOOD KETONE BODY INCREASED] HYPERGLYCEMIA [HYPERGLYCAEMIA] AFTER PRESSING THE DOSE COUNTER THE PEN DOESN'T INJECT ALL THE INSULIN AMOUNTS [DEVICE DELIVERY SYSTEM ISSUE] CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM EGYPT WAS REPORTED BY A PATIENT FAMILY MEMBER OR FRIEND AS "HAD ACETONE IN HIS BLOOD(BLOOD KETONE BODY INCREASED)" WITH AN UNSPECIFIED ONSET DATE, "HYPERGLYCEMIA(HYPERGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE, "AFTER PRESSING THE DOSE COUNTER THE PEN DOESN'T INJECT ALL THE INSULIN AMOUNTS(INACCURATE DELIVERY BY DEVICE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A MALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", NOVORAPID PENFILL (INSULIN ASPART) (DOSE, FREQUENCY & ROUTE USED-UNK) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS". PATIENT HEIGHT, WEIGHT AND BODY MASS INDEX NOT MENTIONED CURRENT CONDITION: DIABETES MELLITUS. (TYPE AND DURATION NOT MENTIONED) ON AN UNKNOWN DATE THE PATIENT HAD SUFFERED FROM HYPERGLYCEMIA AND HAD ACETONE IN HIS BLOOD DUE TO THE TECHNICAL PROBLEM OF PATIENTS NOVOPEN 4 ( USING NOVORAPID PENFILL ), AFTER PRESSING THE DOSE COUNTER THE PEN DOESN'T INJECT ALL THE INSULIN AMOUNTS PEN TRAINING WAS OFFERED BUT THE PATIENT REFUSED TO PERFORM THE STEPS BATCH NUMBERS: NOVOPEN 4: LVG5B14 NOVORAPID PENFILL: WAS REQUESTED ACTION TAKEN TO NOVORAPID PENFILL WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "HAD ACETONE IN HIS BLOOD(BLOOD KETONE BODY INCREASED)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "HYPERGLYCEMIA(HYPERGLYCEMIA)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "AFTER PRESSING THE DOSE COUNTER THE PEN DOESN'T INJECT ALL THE INSULIN AMOUNTS(INACCURATE DELIVERY BY DEVICE)" WAS NOT REPORTED. PRELIMINARY MANUFACTURER'S COMMENT: (B)(6) 2023: THE SUSPECTED DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED FOR EVALUATION. NO CONCLUSION IS REACHED.

    Description of Event or Problem · 0

    CASE DESCRIPTION: INVESTIGATION RESULTS: NOVOPEN 4, BATCH NUMBER: LVG5B14. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: IMDRF CODES AND INVESTIGATION RESULTS ADDED, RELEVANT FIELDS IN EU/CA TAB UPDATED, NARRATIVE WAS UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: 16-MAY-2023: THE SUSPECTED DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED FOR EVALUATION. THE BATCH TREND ANALYSIS AND REFERENCE SAMPLE EXAMINATION REVEALED NOTHING ABNORMAL. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. 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. EVENTS ARE LISTED. THIS SINGLE CASE REPORT IS NOT CONSIDERED TO CHANGE THE CURRENT KNOWLEDGE OF THE SAFETY PROFILE OF NOVORAPID PENFILL. H3 CONTINUED: EVALUATION SUMMARY: NOVOPEN 4, BATCH NUMBER: LVG5B14. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965320 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A LVG5B14

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other