BEUDAMED
    FDA Adverse Event Summary report: N

    NOVOLINPEN

    MDR report key: 36461 · Received September 4, 1996

    Report

    Report Number
    9681822-1996-02068
    Date Received
    September 4, 1996
    Date of Event
    June 1, 1996
    Report Date
    September 4, 1996
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    HYPERGLYCEMIA: A MAN REPORTED THAT HIS WIFE EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS IN 6/96 WHEN USING DEVICE, NEEDLES AND NOVOLIN 70/30 (RDNA) PENFILL CARTRIDGES AND WAS HOSPITALIZED FOR ONE WEEK. HE REPORTED THAT THE PUSHBUTTON ON THE DEVICE WAS NOT WORKING PROPERLY AND THAT THE DEVICE WAS NOT DELIVERING THE CORRECT AMOUNT OF INSULIN. THE HUSBAND ADMINISTERS THE INJECTIONS TO HIS WIFE BECAUSE SHE IS BLIND. ANALYSIS RESULTS OF DEVICE IN QUESTION: TECHNICAL DESCRIPTION 1) DAMAGED DRIVE JAW SLEEVE DUE TO MISUSE. JAW LOCK COLLAR NOT TURNED IN LOCKED POSITION BEFORE PUSHBUTTON WAS DEPRESSED. MEDICAL CONSEQUENCES: NO INSULIN ADMINISTRATION POSSIBLE, BUT THE DEFECT IS VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOLINPEN INSULIN DELIVERY DEVICE KZE NOVO NORDISK A/S NA E544

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization LASIX HEART MEDS (NOT SPECIFIED)| CONCOMITANT DRUGS STRENGTH FROM TO NOVOLIN 70/30