BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1230891 · Received November 6, 2008

    Report

    Report Number
    1823260-2008-08203
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULTS OF 425 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 175 MG/DL ON THE PROFESSIONAL SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. REPORTER DISCONNECTED BEFORE THE ADDRESS INFORMATION COULD BE OBTAINED OR A REQUEST FOR THE RETURN OF THE PRODUCT COULD BE MADE; AND SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK