BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1002116 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01737
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE ACCU-CHEK INFORM SYS 2.

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE PT WAS TESTED WITH A BLOOD GLUCOSE RESULT OF "LO" (LESS THAN 10MG/DL) ON ACCU-CHEK INFORM SYS 1 AND 299MG/DL ON ACCU-CHEK INFORM SYS 2. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN BASED ON THE BLOOD GLUCOSE RESULTS. NO ADVERSE EVENT REPORTED. NEW SYS SENT TO CUSTOMER AND RETURN REQUESTED.

    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 549790

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK