BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1212604 · Received October 24, 2008

    Report

    Report Number
    1823260-2008-07863
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    April 1, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A RESULT IN THE 200-299 MG/DL RANGE, TOOK "0.5 UNITS" OF HIS BYETTA PEN. REPORTER STATED THAT WITHIN 15-20 MINUTES, HE WAS SHAKY, CONFUSED, SWEATY AND THEN HE PASSED OUT. REPORTER ALLEGED SHE OBTAINED DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 70 MG/DL, 60 MG/DL AND 40 MG/DL ON THE CUSTOMER WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER STATED SHE FORCE-FED THE CUSTOMER JUICE AND GLUCOSE TABS. 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. REPORTER STATED THE STRIPS USED ARE NO LONGER AVAILABLE AND SO NO PRODUCT WILL BE RETURNED FOR EVAL.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention BYETTA| ACTOS| AMARYL