BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTRA 1400C

    MDR report key: 91105 · Received May 12, 1997

    Report

    Report Number
    2424022-1997-00001
    Event Type
    Other
    Date Received
    May 12, 1997
    Date of Event
    April 3, 1997
    Report Date
    May 6, 1997
    Manufacturer
    MEDICAL LABORATORY AUTOMATION, INC.
    Product Code
    GKP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT (ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER) REPORTED AN "NCD- NO CLOT DETECTED, AND THE USER OF THE INSTRUMENT REPORTED THE RESULT AS GREATER 180 SECONDS. IN ACTUALITY THE RESULT WAS A QUICK CLOT (DO NOT HAVE ACTUAL RESULT). THE LABORATORY INFORMED CO THAT THE PT WAS MISTREATED, UNABLE TO DETERMINE IF IT HAD ANY ADVERSE EFFECT (PT HAD SEVERAL PROBLEMS). THERE WAS NO REPORT OF A SERIOUS INJURY OR DEATH. ALSO, THE LABORATORY SUPERVISOR HAS INFORMED CO THAT THEY HAVE EDUCATED THEIR STAFF, YET THIS HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRA 1400C COAGULATION INSTRUMENT GKP MEDICAL LABORATORY AUTOMATION, INC. ELECTRA 1400C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other