BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022679 · Received April 1, 2008

    Report

    Report Number
    1823260-2008-02904
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 13, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE ACCU-CHEK INFORM SYS 1. REFERENCE MEDWATCH WITH A1 PT FOR SUSPECT DEVICE ACCU-CHEK INFORM SYSTEM 2.

    Description of Event or Problem · 1

    THE RPTR STATES THAT THE PT WAS TESTED AND HIS BLOOD GLUCOSE RESULT WAS "RRLO" (LESS THAN 30MG/DL) ON ACCU-CHEK INFORM SYSTEM 1 IN COMPARISON TO HIS BLOOD GLUCOSE RESULT IN THE 300'S (MG/DL) ON ACCU-CHEK INFORM SYS 2. THE RESULTS WERE OBTAINED WITHIN A 10 MIN TIMEFRAME. NO REPORTED ACTIONS TAKEN. 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 550089

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK