BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1243247 · Received November 7, 2008

    Report

    Report Number
    1823260-2008-08233
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER (FIRE DEPARTMENT) ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE RESULTS OF 182 MG/DL ON A PT USING THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH RESULTS OF 70-79 MG/DL TWICE ON ANOTHER PROFESSIONAL SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINS. REPORTER INDICATED THEY WERE CALLED BECAUSE THE PT WAS HAVING DIFFICULTY BREATHING AND HE WAS TAKEN TO THE HOSPITAL FOR THAT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 550515

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR