BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1222389 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08182
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 12, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTS THAT THE CUSTOMER'S BG WAS 400MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. HE WAS GIVEN 4 UNITS OF HUMALOG. THIRTY MINUTES LATER, HE EXPERIENCED SHAKINESS AND SEIZURE-LIKE ACTIVITY. THE CALLER ALSO STATES THAT THE CUSTOMER WAS "CONSCIOUS" AND "UNRESPONSIVE". THE PARAMEDICS TESTED THE CUSTOMER AND OBTAINED A BG RESULT LESS THAN 40MG/DL ON THE PROFESSIONAL METER. THE CUSTOMER WAS TREATED WITH GLUCOSE GEL AND TRANSPORTED TO THE HOSP. THE CUSTOMER WAS ADMITTED TO THE HOSP. NEW SYSTEM SENT AND RETURNED REQUESTED.

    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 550519

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention HUMALOG