BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1771210 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01584
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 3, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULT OF 83 MG/DL, A RESULT IN THE 100-199 MG/DL RANGE AND A RESULT IN THE 200-299 MG/DL RANGE WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE COMPACT SYSTEM. REPORTER DID NOT INDICATE THAT SHE WAS EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATED THAT SHE SELF-TREATED BY WALKING. NO OTHER 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 20673341

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR GLYBURIDE - TIME UNK, 2.5MG ONCE DAILY