BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1111671 · Received August 13, 2008

    Report

    Report Number
    1823260-2008-06164
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACCU-CHEK ACTIVE S SYSTEM WITHIN 10 MINUTES: 187MG/DL, 147MG/DL AND 330MG/DL. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 22966034

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR AMLODIPINE/BENAZEPRIL - 5 YEARS| SIMVASTATIN - 5 YEARS| GLIPIZIDE XL - 5 YEARS| ECOTRIN - 5 YEARS