BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1133037 · Received August 19, 2008

    Report

    Report Number
    1823260-2008-06324
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    August 2, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT HE OBTAINED THE BLOOD GLUCOSE RESULT OF 520MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. HE DOSED HIMSELF WITH 10 UNITS OF NOVOLOG PER SLIDING SCALE. HE DID NOT EAT AS USUAL DUE TO THE HIGH RESULT. ONE HOUR LATER, HE FELT HYPOGLYCEMIC. HE DID NOT TREAT HIMSELF OR TAKE ACTION. THE CUSTOMER FELT THAT HE SHOULD BE HYPERGLYCEMIC BASED ON THE 520MG/DL RESULT. SIX HOURS LATER, HE CONTINUED TO FEEL HYPOGLYCEMIC AND SUBSEQUENTLY "PASSED OUT". HIS BLOOD GLUCOSE WAS 20MG/DL ON THE PROFESSIONAL METER. HE RECEIVED A GLUCAGON INJECTION FROM THE PARAMEDICS AND FELT BETTER 10-20 MINUTES FOLLOWING TREATMENT. THE CUSTOMER WAS TRANSPORTED TO THE HOSPITAL. HIS BLOOD GLUCOSE WAS 160MG/DL ON THE HOSPITAL METER. HE WAS GIVEN FOOD TO EAT. HE WAS NOT ADMITTED TO THE HOSPITAL. NEW SYSTEM SENT AND RETURN REQUESTED. THE CUSTOMER STATES THAT HE DOES NOT HAVE THE ORIGINAL STRIP VIAL CONTAINER.

    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 58 YR Required Intervention LANTUS 6 MONTHS| NOVOLOG 6 MONTHS