BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 115336 · Received August 19, 1997

    Report

    Report Number
    1823260-1997-00071
    Event Type
    Malfunction
    Date Received
    August 19, 1997
    Date of Event
    July 24, 1997
    Report Date
    July 24, 1997
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STANDARD DISCLAIMER ON FILE.

    Description of Event or Problem · 1

    HOSP REPORTS AN INCIDENT IN WHICH A NEONATE WAS GIVEN INSULIN BASED ON 375 MG/DL RESULT FROM SUSPECT DEVICE. CONFIRMATORY LAB RESULTS WERE 86MG/DL AND 95 MG/DL. QUALITY CONTROL CHECKS PERFORMED ON THE SUSPECT DEVICE WERE WITHIN RANGE. ALL OTHER TESTS PERFORMED IN NEONATE WARD WERE ACCEPTABLE. HOSP BELIEVES EVENT RELATED TO NEONATE'S HLTH CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING SYSTEM CFR BOEHRINGER MANNHEIM CORP. 768 (METER) 411618/411668/AND

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DAY