BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK ADVANTAGE

    MDR report key: 103351 · Received July 3, 1997

    Report

    Report Number
    1823260-1997-00055
    Event Type
    Injury
    Date Received
    July 3, 1997
    Date of Event
    June 21, 1997
    Report Date
    June 23, 1997
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    STANDARD DISCLAIMER ON FILE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BOTTOMING OUT SINCE PURCHASED DEVICE ONE MONTH AGO. ALLEGES DEVICE READING HIGH. CUSTOMER WAS ADMINISTERING INSULIN (SLIDING SCALE) BASED ON DEVICE READING. TESTED CONTROLS WHEN BEGAN USING DEVICE AND WERE WITHIN RANGE. EMT STARTED IV GLUCOSE, ER GAVE GLUCOSE ORALLY. HAS NOT TESTED WITH CONTROLS RECENTLY. PROBABLE EXPOSED STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE CFR BOEHRINGER MANNHEIM CORP. 768 (METER) 400420 (STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R