BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022665 · Received April 1, 2008

    Report

    Report Number
    1823260-2008-02898
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR STATES CUSTOMER WAS INCOHERENT WITH BLOOD GLUCOSE RESULT OF 62 MG/DL OBTAINED ON THE ADVANTAGE SYSTEM. THE RPTR TREATED HER WITH GLUCOSE GEL; PARAMEDICS ARRIVED, AND RESULT ON PARAMEDIC'S METER WITHIN 10 MINUTES OF CUSTOMER'S RESULT WAS 27 MG/DL. NO MEDICAL TREATMENT REQUIRED, AND SYMPTOMS IMPROVED. 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 549617

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HUMULIN 70/30 20 UNITS AM| HUMULIN 70/30 25 UNITS PM