BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1181965 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07066
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 185 MG/DL AND 93 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH RESULTS OF 42 MG/DL AND 60 MG/DL ON THE EMT'S SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT HE WAS UNRESPONSIVE WHEN THE EMTS WERE CALLED, HE REGAINED CONSCIOUSNESS WHILE THEY WERE THERE, AND HE DRANK ORANGE JUICE AFTER THE RESULTS OF 185 MG/DL AND 42 MG/DL WERE OBTAINED. REPORTER STATED THE RESULTS OF 93 MG/DL AND 60 MG/DL WERE OBTAINED AFTER HE DRANK THE ORANGE JUICE. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS -LFR LFR ROCHE DIAGNOSTICS CORP. 550615

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HUMALOG - 10 YRS - 2-3 UNITS TWICE DAILY