BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 862277 · Received March 23, 2007

    Report

    Report Number
    1823260-2007-02352
    Event Type
    Malfunction
    Date Received
    March 23, 2007
    Date of Event
    February 28, 2007
    Report Date
    March 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED A RESULT OF 269 MG/DL ON THE ADVANTAGE TEST SYSTEM AND 84 MG/DL ON A LAB DRAWN WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. INFO SUGGESTS COMPARISON PERFORMED AT MEDICAL FACILITY. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. NO QUALITY CONTROLS WERE USED. ADANTAGE TEST SYSTEM: TEST STRIP LOT 549603, EXP 4/30/08, CAT/2030373.

    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 * 549603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA FREQUENCY / DURATION| VANCOMYCIN - 1 GM, FREQUENCY UNK| KETAMINE SPRAY TOPICALLY NI ON DOSE/| FREQUENCY /DURATION| MYCOLOG CR, NI ON DOSE/FREQUENCY/DURATION| LEXAPRO - NI ON DOSE/FREQUENCY / DURATION| PREVACID - 30 MG, FREQUENCY UNK| REGULAR INSULIN - NI ON DOSE/ FREQUENCY DURATION| ATIVAN - 0.5 MG, FREQUENCY UNK| HYDROCORTISONE CR, NI ON DOSE/FREQUENCY/DURATION| RESTORIL - 30 MG/ FREQUENCY UNK| LEVOTHRYOXINE - 200 MG, UNK FREQUENCY| LEVAQUIN - 500 MG, UNK FREQUENCY| FLUTICASONE NASAL SPRAY - NI ON DOSE/| DECADRON - NI ON DOSE/ FREQUENCY / DURATION