BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1230899 · Received November 6, 2008

    Report

    Report Number
    1823260-2008-08209
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 29, 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
    CA, US

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS UNSURE WHICH RESULTS WERE OBTAINED ON WHICH SYSTEM. THIS MEDWATCH REPORT IS FOR ONE OF THE SUSPECT DEVICES USED (LOT NUMBER 550631, EXPIRATION DATE 08/31/2009). REFERENCE MEDWATCH REPORT WITH A1 PATIENT FOR THE OTHER SUSPECT DEVICE USED.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 39 MG/DL ON A NEONATE USING THE INFORM SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 20 MG/DL ON THE LAB SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER ALLEGED, AT ANOTHER TIME, OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 53 MG/DL ON THE SAME NEONATE USING THE INFORM SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 32 MG/DL ON THE LAB SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER ALLEGED, AT ANOTHER TIME, OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 63 MG/DL ON THE SAME NEONATE USING THE INFORM SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 41 MG/DL ON THE LAB SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 550631

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA