BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1060825 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04757
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE VALUE OF 49 MG/DL ON A NEONATE PT USING THE GTS ADVANTAGE SYSTEM BACK TO BACK WITH A RESULT OF 31 MG/DL ON A LAB SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NEONATE PT WAS HAVING SYMPTOMS OF LOW BLOOD GLUCOSE AND WAS GIVEN FORMULA AS TREATMENT BASED ON THE METER READING. 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 CORP. 550630

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK