BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1222390 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08187
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 30, 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
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTS THAT HE FELT HYPOGLYCEMIC AND OBTAINED THE BLOOD GLUCOSE RESULT OF 146MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. HE "PASSED OUT" A FEW MINUTES LATER. THE CUSTOMER'S WIFE POURED APPLE JUICE DOWN HIS MOUTH WHILE HE WAS "PASSED OUT". THE CUSTOMER "CAME TO" AFTER TREATMENT. THE EMERGENCY MEDICAL TECHNICIANS TESTED THE CUSTOMER AND OBTAINED THE BLOOD GLUCOSE RESULT OF 184MG/DL ON THE PROFESSIONAL METER. NO ADDITIONAL TREATMENT GIVEN TO THE CUSTOMER. THE CUSTOMER DECLINED TO GO TO THE HOSP. NEW SYSTEM SENT AND RETURN 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 550090

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention HUMULIN NPH