BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083496 · Received July 28, 2008

    Report

    Report Number
    1823260-2008-05818
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    RPTR ALLEGED THE CUSTOMER HAD VERY SLURRED SPEECH BEFORE PASSING OUT AND SHE OBTAINED A RESULT OF 246 MG/DL ON THE ADVANTAGE SYS. RPTR STATED THAT WITHIN 10 MINS OF THAT RESULT, THE EMTS ARRIVED AND OBTAINED A 39 MG/DL ON THEIR SYSTEM. RPTR STATED THAT THEY TREATED THE CUSTOMER WITH AN IV AND A PEANUT BUTTER SANDWICH ONCE HE WAS COHERENT, THEN TOOK THE CUSTOMER TO THE HOSP WHERE BLOOD WORK WAS DONE. RPTR ALSO STATED THAT THE STRIPS THE CUSTOMER IS USING WERE STORED OUTSIDE OF THEIR ORIGINAL VIAL WHICH LABELING ADVISED AGAINST. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT REC'D. 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 550509

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention NOVOLIN - 1 MONTH 60 UNITS DAILY