BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 513655 · Received February 26, 2004

    Report

    Report Number
    1823260-2004-00088
    Event Type
    Injury
    Date Received
    February 26, 2004
    Date of Event
    November 28, 2003
    Report Date
    February 13, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER USED THE DEVICE TO CHECK THEIR BLOOD GLUCOSE PRIOR TO GOING TO BED. THEY OBTAINED A RESULT OF 300 MG/DL AND SKIPPED THEIR SNACK DUE TO THE READING. FAMILY MEMBER FOUND PT PASSED OUT LATER. EMERGENCY MEDICAL TECHS WERE CALLED AND THEY CHECKED PATIENT'S GLUCOSE ON THEIR EQUIPMENT AND THE LEVEL WAS 21 MG/DL. EMERGENCY MEDICAL TECHS GAVE PT GLUCOSE AND GRAPE JUICE. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION. CONTROLS WERE NOT USED ON THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS CORP. NA 546647

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention