BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTRA 1000C AUTOMATIC COAGULATION TIMER

    MDR report key: 56086 · Received December 11, 1996

    Report

    Report Number
    2424022-1996-00002
    Event Type
    Other
    Date Received
    December 11, 1996
    Date of Event
    October 31, 1996
    Report Date
    December 9, 1996
    Manufacturer
    MEDICAL LABORATORY AUTOMATION, INC.
    Product Code
    GKP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    LAB RAN PTS ON THE AUTOMATIC COAGULATION TIMER, AND THE INSTRUMENT REPORTED THE RESULT AS "NCD". THE LAB REPORTED THE RESULT OUT AS GREATER THAN 70 SECONDS. THE PT WAS TREATED WITH VIT K. PT TEST WAS RERUN LATER USING A FIBROMETER, RESULT WAS 7.6 SECONDS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRA 1000C AUTOMATIC COAGULATION TIMER AUTOMATIC COAGULATION TIMER GKP MEDICAL LABORATORY AUTOMATION, INC. ELECTRA 1000C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other