BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 623044 · Received July 26, 2005

    Report

    Report Number
    1823260-2005-02169
    Event Type
    Injury
    Date Received
    July 26, 2005
    Date of Event
    July 2, 2005
    Report Date
    July 10, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED RECEIVING ELEVATED BLOOD GLUCOSE RESULTS (> 500 MG/DL), WHILE USING THE SUSPECT DEVICE. PATIENT INDICATED THAT THEY SOUGHT TREATMENT, IN THE EMERGENCY ROOM, FOR HYPERGLYCEMIA. PATIENT STATED THAT, WHEN TESTED WITH THE HOSPITAL'S BLOOD GLUCOSE MONITOR, THE VALUES WERE 100 - 125 MG/DL LOWER THAN THOSE OBTAINED WHILE USING THE SUSPECT DEVICE. PATIENT WAS ADMITTED TO THE HOSPITAL, FOR 6 DAYS, AND WAS TREATED WITH INSULIN. UPON RELEASE, PATIENT WAS GIVEN A SLIDING SCALE, WITH WHICH TO DETERMINE THEIR INSULIN DOSAGE. PATIENT STATED THAT, SINCE BEING DISCHARGED FROM THE HOSPITAL, THEY HAVE TWICE SOUGHT TREATMENT, FOR HIGH BLOOD GLUCOSE, IN THE EMERGENCY ROOM. CONTROL TESTING HAD NOT BEEN PERFORMED ON SUSPECT DEVICE. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT AS SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS NA 548567

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R