BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1011719 · Received March 10, 2008

    Report

    Report Number
    1823260-2008-02257
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 153 MG/DL BACK TO BACK WITH A RESULT OF 80 MG/DL MG/DL ON THE COMPACT PLUS SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER ALLEGED THAT WITHIN 10 MINUTES OF THE 80 MG/DL, OTHER RESULTS OF 300 MG/DL, 172 MG/DL, AND 148 MG/DL WERE ALSO OBTAINED ON THE SAME SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED AFTER THE READINGS WERE OBTAINED. NO ADVERSE EVENT REPORTED. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HUMULIN N - 10 YRS