BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK COMPACT

    MDR report key: 511942 · Received February 16, 2004

    Report

    Report Number
    1823260-2004-00073
    Event Type
    Injury
    Date Received
    February 16, 2004
    Date of Event
    December 28, 2003
    Report Date
    February 6, 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 AND OBTAINED A RESULT OF 102 MG/DL PRIOR TO GOING TO BED. PATIENT DOSED INSULIN AND WAS FOUND UNCONSCIOUS ABOUT 6 1/2 HOURS LATER. EMTS WERE CALLED AND THEY CHECKED THEIR GLUCOSE AND THE LEVEL WAS 17 MG/DL. PATIENT WAS GIVEN GLUCOSE IN THE AMBULANCE AND TAKEN TO THE HOSP. CONTROLS WERE NOT USED ON THE SYSTEM. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK COMPACT BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization