BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1023852 · Received April 2, 2008

    Report

    Report Number
    1823260-2008-02938
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 274 MG/DL, 350 MG/DL, 174 MG/DL, 124 MG/DL AND 120 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. REPORTER INDICATED SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 20670941

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR KLONOPIN - 2 YEARS - 1 MG ONCE DAILY| REGLAN - 1 YEAR - DOSAGE UNK TWICE DAILY| WELLBUTRIN - 2 YEARS - 150 MG TWICE DAILY| AMBIEN - 2 YEARS - 10 MG ONCE DAILY| SKELAXIN - 1 MONTH - 800 MG TWICE DAILY| MOTRIN - 1 MONTH - 800 MG TWICE DAILY| FEMARA - 1 YEAR 2.5 MG ONCE DAILY| GLIPIZIDE - 1 YEAR 5 MG TWICE DAILY| GLUCOPHAGE - 1 YEAR 500 MG TWICE DAILY