BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 333616 · Received May 17, 2001

    Report

    Report Number
    1823260-2001-00105
    Event Type
    Injury
    Date Received
    May 17, 2001
    Date of Event
    May 13, 2001
    Report Date
    May 14, 2001
    Manufacturer
    ROCHE DIAGNOSITCS
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT USED THE SUSPECT DEVICE TO CHECK THEIR BLOOD GLUCOSE. THE PT OBTAINED A RESULT OF 119MG/DL IN THE MORNING. THE PT FELT BAD PHYSICALLY AND CONTINUED TO TEST, GETTING RESULTS IN THE 4 TO 500 RANGE (427, 503, 224, 113, HI, AND 489MG/DL). AFTER RECEIVING THE 489MG/DL RESULT, PT WENT TO THE ER. THE ER TESTED PT ON THEIR OWN METER, WHICH READ 210MG/DL. PT SAID PT WAS THEN TREATED WITH AN IV AND POSSIBLY INSULIN. THE HOSPITAL ALSO RAN A LAB GLUCOSE WHICH WAS 150MG/DL. PT USED A GLUCOSE CONTROL SOLUTION ON THE TEST STRIPS IN USE AND THE CONTROL WAS IN RANGE, L1 CONTROL = 62 (50-80). THE SUSPECT DEVICE WAS REPLACED AND AUTHORIZED FOR RETURN TO THE MANUFACTURER FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23665 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSITCS NA 534293

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention