BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1033171 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03471
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED NEONATE PT WITH SEVERAL METER-TO-LAB COMPARISONS ON THE INFORM SYSTEM: 25MG/DL TO 30-SOMETHING (MG/DL), 31 MG/DL TO 46 MG/DL, 21 MG/DL AND 35 MG/DL TO 59 MG/DL, 24 MG/DL TO 81 MG/DL. 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 LFR ROCHE DIAGNOSTICS 550547

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA MEDICAL PRODUCTS UNK