BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 39758 · Received September 24, 1996

    Report

    Report Number
    1823260-1996-00102
    Event Type
    Injury
    Date Received
    September 24, 1996
    Date of Event
    September 9, 1996
    Report Date
    September 18, 1996
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SPOUSE OF ELDERLY DIABETIC REPORTED A HYPOGLYCEMIC EVENT WHICH LED TO HOSPITALIZATION OF THE DIABETIC. NO INFO WAS AVAILABLE ON THE TREATMENT REC'D. THE DEVICE HAD BEEN PROVIDING ELEVATED BLOOD VALUE PRIOR TO THE EVENT. AN ADD'L 5 UNITS OF INSULIN WAS ADMINISTERED IN THE EVENING PRIOR TO THE EVENT AS DIRECTED BY PHYSICIAN. THE DIABETIC HAD NOT BEEN STORING THE TEST STRIPS AS DIRECTED IN THE LABELING. QUALITY CONTROL CHECKS AFTER THE EVENT INDICATED THAT THE STRIPS WERE DAMAGED. LABELING CLEARLY INDICATES THAT UNUSUALLY HIGH RESULTS CAN BE CAUSED BY STORING THE STRIPS IN THE VIAL WITHOUT CAP BEING TIGHTLY SEALED.

    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) 400275(STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization