BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1317010 · Received January 9, 2009

    Report

    Report Number
    1823260-2009-00212
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Date of Event
    December 17, 2008
    Report Date
    January 9, 2009
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE FOLLOWING DISCREPANT RESULTS, ON TWO SEPARATE OCCASIONS, ON HIS ACCUCHEK COMPACT SYSTEM WITHIN 10 MINUTES: 413 MG/DL, 77 MG/DL AND 47 MG/DL, AND 62 MG/DL, 313MG/DL, AND 274 MG/DL. NO ACTION WAS TAKEN BASED ON THE DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT, HOWEVER, STRIPS ARE NOT AVAILABLE FOR RETURN.

    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 CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR ACTOS 30 MG DAILY - 3 YEARS| LYRICA 150 MG TWICE DAY| LISINOPRIL 20 MG DAILY - 1 YEAR