BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTRA 1600C AUTOMATIC COAGULATION ANALYZER

    MDR report key: 145706 · Received January 22, 1998

    Report

    Report Number
    2424022-1998-00002
    Event Type
    Other
    Date Received
    January 22, 1998
    Date of Event
    December 15, 1997
    Report Date
    December 16, 1997
    Manufacturer
    MEDICAL LABORATORY AUTOMATION
    Product Code
    GKP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT TREATED UNNECESSARILY- ELECTRA 1600C RUNNING PT, RESULT OBTAINED WAS "NCD- NO CLOT DETECTED", OPERATOR REPORTED RESULT OUT AS A LONG CLOT TIME (GREATER THAN 106 SECONDS). PT WAS GIVEN VITAMIN K. THE NCD WAS REPORTED ERRONEOUSLY AS GREATER THAN 106 SECONDS. AFTER RERUNNING THE TEST LATER, THE CLOT TIME WAS SHORT- 8 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRA 1600C AUTOMATIC COAGULATION ANALYZER AUTOMATIC COAGULATION ANALYZER GKP MEDICAL LABORATORY AUTOMATION ELECTRA 1600C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other