BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1780604 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08467
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    September 10, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED HAVING DISCREPANT BLOOD GLUCOSE RESULTS OF 48 MG/DL BACK TO BACK WITH A RESULT OF 122 MG/DL WHEN TESTING WAS PERFORMED 1 MINUTE APART ON THE COMPACT SYSTEM. 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 20665141

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR LIPITOR - 5 YRS, 40MG ONCE DAILY| FOLIC ACID - 10 YRS, 1MG ONCE DAILY| LISINOPRIL - 4 YRS, 5MG ONCE DAILY| CYCLOBENZAPRINE - 2 YRS, 10MG ONCE DAILY| AVISTA - 15 YRS, 60MG ONCE DAILY