BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CA-1000

    MDR report key: 61154 · Received January 6, 1997

    Report

    Report Number
    1025506-1997-00001
    Event Type
    Injury
    Date Received
    January 6, 1997
    Date of Event
    November 29, 1996
    Report Date
    January 6, 1997
    Manufacturer
    TOA MEDICAL ELECTRONICS
    Product Code
    GKP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE LAB CONDUCTED PTT TESTING ON A SPECIMEN COLLECTED FROM A 93-YR-OLD FEMALE PT ON HEPARIN. THE RESULT OBTAINED WAS ASSOCIATED WITH A FLAT COAGULATION CURVE. DESPITE LABELING INSTRUCTIONS TO THE CONTRARY, THE LAB REPORTED THIS RESULT. BASED UPON THIS FALSELY SHORT REPORTED PTT TIME, THE PT WAS GIVEN AN ADD'L HEPARIN BOLUS AND THE HEPARIN DRIP WAS INCREASED. THE PT BEGAN BLEEDING FROM THE IV SITE AND THE NG TUBE. PROTAMINE WAS ADMINISTERED (10 MG IV). THE PT WAS LATER DISCHARGED WITHOUT SERIOUS PERMANENT EFFECTS. THE SOFTWARE FOR THIS INSTRUMENT HAS BEEN MODIFIED TO MITIGATE THE FLAT COAGULATION CURVE ISSUE AND IS CURRENTLY PENDING REVIEW UNDER 510(K) PREMARKET NOTIFICATION, DOCUMENT CONTROL NUMBER K964946.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CA-1000 AUTOMATED COAGULATION ANALYZER GKP TOA MEDICAL ELECTRONICS CA-1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention HEPARIN