BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON TEST TUBE

    MDR report key: 27592 · Received October 30, 1995

    Report

    Report Number
    MW1007509
    Event Type
    Malfunction
    Date Received
    October 30, 1995
    Date of Event
    October 12, 1995
    Report Date
    October 18, 1995
    Manufacturer
    INTL TECHNIDYNE CORP.
    Product Code
    JBT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TEST TUBES FOUND TO BE DEFECTIVE DURING DAILY CALIBRATION. CALIBRATIONS WERE EXCESSIVELY HIGH. THE MFR WAS NOTIFIED AND WILL REPLACE THIS LOT NUMBER BY 10/13/95. DEFECTIVE LOT RETURNED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON TEST TUBE TEST TUBE JBT INTL TECHNIDYNE CORP. P-215 NESF 85

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other