BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE WITH GTS

    MDR report key: 38199 · Received September 12, 1996

    Report

    Report Number
    1823260-1996-00096
    Event Type
    Injury
    Date Received
    September 12, 1996
    Date of Event
    August 27, 1996
    Report Date
    September 10, 1996
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STANDARD DISCLAIMER ON FILE.

    Description of Event or Problem · 1

    A MALE NON-COMPLIANT INSULIN DIABETIC WAS SEEN IN THE ER. NURSE TESTED PT AND RECEIVED "L ERROR" AND "USER ERROR" MESSAGES ON THE DEVICE. THE NURSE ASSUMED THIS MEANT THAT THE BLOOD GLUCOSE LEVEL WAS LOW AND TREATED WITH GLUCOSE, PRIOR TO RECEIPT OF LAB RESULTS. LAB RESULTS FROM SERUM SAMPLES DRAWN PRIOR TO TREATMENT WAS 1200 MG/DL, AFTER TREATMENT WAS 1600 MG/DL. THE LAB SUBSEQUENTLY TESTED EDTA SAMPLE (PRIOR TO TREATMENT) ON THE DEVICE THE RN HAD USED AND GOT "HI" MESSAGE. CONTROLS RUN ON THE METER THAT DAY WERE WITHIN RANGE. PT WAS ADMITTED TO THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE WITH GTS BLOOD GLUCOSE MONITORING SYSTEM CFR BOEHRINGER MANNHEIM CORP. 404 411630 (STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention