BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 39755 · Received September 24, 1996

    Report

    Report Number
    1823260-1996-00101
    Event Type
    Injury
    Date Received
    September 24, 1996
    Date of Event
    September 9, 1996
    Report Date
    September 10, 1996
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FAMILY MEMBER REPORTS THAT DIABETIC WAS HOSPITALIZED AND GIVEN IV GLUCOSE FOR A HYPOGLYCEMIC EVENT. THE DEVICE HAD BEEN PROVIDING ELEVATED BLOOD GLUCOSE RESULTS FOR SEVERAL DAYS. THE DIABETIC HAD BEEN WITH HOLDING FOOD INTAKE BASED ON DEVICE RESULTS. HOSP EVALUATED DEVICE AND DETERMINED THAT TEST STRIPS WERE DAMAGED. DIABETIC HAD QUALITY CONTROL SOLUTIONS BUT HAD NEVER USED THEM TO CHECK THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING TEST STRIPS CFR BOEHRINGER MANNHEIM CORP. 768 (METER) 400294 (STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention