BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLA ELECTRA 1400C

    MDR report key: 274213 · Received April 18, 2000

    Report

    Report Number
    MW1018691
    Event Type
    Injury
    Date Received
    April 18, 2000
    Date of Event
    March 14, 2000
    Report Date
    April 3, 2000
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT HAD ABNORMAL PROTHROMBIN TIME TEST RESULT. PT WAS REDRAWN TO VERIFY. RESULTS WERE STILL ABNORMAL. PT RECEIVED VITAMIN K IN EMERGENCY DEPT. PT'S SPECIMEN WAS RUN AGAIN AND FOUND TO BE IN RANGE. EXAMINATION OF THE ANALYZER SHOWED THAT IT HAD LOST TEMPERATURE CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MLA ELECTRA 1400C COAGULATION ANALYZER GKP INSTRUMENTATION LABORATORY CO. MLA 1400 C *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization COUMADIN DAILY.