BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOPEN 3 (INSULIN DELIVERY DEVICE) NA

    MDR report key: 1530852 · Received November 10, 2009

    Report

    Report Number
    9681821-2009-00043
    Event Type
    Other
    Date Received
    November 10, 2009
    Date of Event
    September 12, 2009
    Report Date
    October 6, 2009
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    19-938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PRODUCT: NOVOPEN 3. LOT NO: 951802. NOTHING ABNORMAL WAS FOUND REGARDING TO DOSAGE ACCURACY.

    Description of Event or Problem · 1

    HYPOGLYCEMIA WITH LOSS OF CONSCIOUSNESS [HYPOGLYCEMIC UNCONSCIOUSNESS]. CASE DESCRIPTION: MEDICAL DEVICE INFO: CLASS IIB. THIS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY MEDICAL DOCTOR AND ENDOCRINOLOGIST AS "TWO EPISODES OF HYPOGLYCAEMIA WITH LOSS OF CONSCIOUSNESS" AND CONCERNS A (B)(6) MALE PT TREATED WITH NOVOPEN 3 (INSULIN DELIVERY DEVICE) FOR "DEVICE THERAPY" AND NOVORAPID (RAPID-ACTING INSULIN ASPART) (B)(6) 2009 AND ONGOING FOR "TYPE 1 DIABETES MELLITUS." PT'S HEIGHT: (B)(6). MEDICAL HISTORY INCLUDES TYPE 1 DIABETES MELLITUS SINCE (B)(6) 1993, APPENDICECTOMY ON (B)(6) 2000 AND AMYGDALECTOMY ON (B)(6) 2001 (NOT CODED IN (B)(4)). ON (B)(6) 2009, THE PT EXPERIENCED HYPOGLYCEMIA WITH LOSS OF CONSCIOUSNESS AFTER 4 IU INJECTION OF NOVORAPID NOVOPEN 3 IN POSTPRANDIAL IN EVENING WHILE HIS BLOOD GLYCEMIA WAS 3 G/L. THE PT WAS TREATED WITH GLUCAGEN INTRAMUSCULAR INJECTION. ON (B)(6) 2009, NOVOPEN 3 WAS CHANGED TO ANOTHER UNSPECIFIED DEVICE. ON UNK DATES, THE PT WAS CONSIDERED "RECOVERED" FROM BOTH EVENTS. ANALYSIS REPLY: PRODUCT; NOVORAPID PENFILL. LOT NO: XT60172. DRUG CONCLUSION: THE RETURNED PRODUCT WAS EXAMINED VISUALLY. FURTHERMORE, THE PARAMETERS IDENTITY, ASSAY, DEGRADATION, AND INSULIN APART RELATED IMPURITIES WERE EXAMINED. THE PRODUCTS WERE FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECS. THE PREPARATION WAS FOUND TO BE NORMAL. PRODUCT: NOVOPEN 3. LOT NO: 951802. DEVICE CONCLUSION: VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE DOSE ACCURACY WAS MEASURED BY WEIGHING. THE PENFILL CARTRIDGE RETURNED WITH THE DELIVERY DEVICE WAS USED. THE RESULT WAS WITHIN ACCEPTABLE LIMITS. THE PEN DOSES ACCURATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN 3 (INSULIN DELIVERY DEVICE) NA INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA 951802

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention LANTUS (INSULIN GLARGINE)