BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 951676 · Received November 15, 2007

    Report

    Report Number
    1823260-2007-09968
    Event Type
    Malfunction
    Date Received
    November 15, 2007
    Date of Event
    October 25, 2007
    Report Date
    November 15, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 233, 119 AND 113 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO HYPOGLYCEMIC OR HYPERLYCEMIC SYMPTOMS WERE REPORTEDLY EXPERIENCED. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20669741

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR ALTACE 2 YRS - 10 MG TWICE DAILY| ASPIRIN - 81 MG ONCE DAILY| GLYBURIDE 8 MG ONCE DAILY| LIPITOR 20MG ONCE DAILY| LANTUS 5 YRS 15-25 UNITS PER SCALE ONCE DAILY