BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT

    MDR report key: 1230043 · Received November 12, 2008

    Report

    Report Number
    1823260-2008-08338
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    November 2, 2008
    Report Date
    November 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT OF HYPOGLYCEMIA REQUIRING HOSPITALIZATION AT A TIME WHEN HER DAUGHTER ATTEMPTED, WAS UNABLE TO USE HER COMPACT SYSTEM DUE TO NO POWER. SHE HAD LAST SUCCESSFULLY USED THE SYSTEM ONE DAY PRIOR. STATED BATTERIES WERE OVER 1 YR OLD. REPLACEMENT PRODUCT SENT; PRODUCT RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization ACTOS 60 MG/DAY "FEW YEARS"| GLIPIZIDE 30 MG/DAY "LONG TIME"