BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACER II

    MDR report key: 39373 · Received September 20, 1996

    Report

    Report Number
    1823260-1996-00090
    Event Type
    Injury
    Date Received
    September 20, 1996
    Date of Event
    August 19, 1996
    Report Date
    September 19, 1996
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT HER HUSBAND, A 66 YEAR OLD PT DIAGNOSED AS A TYPE II DIABETIC 37 YRS AGO, WAS HOSPITALIZED AND TREATED WITH INSULIN AND IV MEDICATION FOR HIGH BLOOD SUGAR (800 BY HOSP LABS). THE PT'S DEVICE READ 154(TIME AND TREATMENT BETWEEN THE TWO READINGS WAS NOT REPORTED). THE PT HAD NOT TAKEN HIS MEDICATION BECAUSE OF THE CO DEVICE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACER II BLOOD GLUCOSE MONITORING SYSTEM CFR BOEHRINGER MANNHEIM CORP. 780 (METER) 259088(STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization