BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD

    MDR report key: 746576 · Received September 3, 2005

    Report

    Report Number
    MW1036520
    Event Type
    Injury
    Date Received
    September 3, 2005
    Date of Event
    August 30, 2005
    Report Date
    September 3, 2005
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    BD TEST STRIPES READING HIGH. NON-DIABETIC -ASSUMED BS=100 TESTED AT 250-. DIABETIC USING TEST RESULTS TO DETERMINE INSULIN DOSE WENT INTO INSULIN SHOCK. CONTROL SOLUTION TEST WAS 253. SHOULD HAVE BEEN BETWEEN 100 AND 140. NOTE CONTROL SOLUTION WAS OUTDATED. TWO TESTS WITH TWO DIFFERENT BD METERS WITHIN 0.5%. SAME TIME, LOCATION, AND STRIPS. COMPARED BD TEST RESULTS WITH NON-BD METER. WITHIN 20% BUT TEST STRIPS FOR NON-BD METER WERE REALLY OLD AND LATER DETERMINED TO BE UNRELIABLE. CONCLUSION: BAD BD TEST STRIPS READING VERY HIGH. BD TEST STRIPS. CODE 22. LOT 4064089. EXP. DATE 2006-03. OPENED ON EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD BLOOD GLUCOSE TEST STRIPS USED WITH BD LOGIC METERS NBW BECTON DICKINSON AND CO. * 4064089

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening