BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1902267 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06813
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE DOES NOT TURN ON WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN ADVANTAGE METER, COMPARED TO A PROFESSIONAL METER, WITHIN 10 MINUTES: 216 MG/DL (ADVANTAGE) AND 94 MG/DL (HEALTH CENTER'S METER) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT 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 ROCHE DIAGNOSTICS 551385

    Patients

    Seq Age Sex Outcome Treatment
    1