BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUMATRAK PROTHROMBIN TIME (PT) TEST

    MDR report key: 1429 · Received September 22, 1992

    Report

    Report Number
    2937793-1992-00001
    Event Type
    Injury
    Date Received
    September 22, 1992
    Date of Event
    July 29, 1992
    Report Date
    August 13, 1992
    Manufacturer
    BIOTRAK, INC.
    Product Code
    GJS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT, A 55 YEAR OLD FEMALE WAS EVALUATED BY THE PHYSICIAN IN THE OFFICE. SIGNIFICANT PAST MEDICAL HISTORY INCLUDED A MITRAL VALVE TREPLACEMENT, HYPEWRTENSION AND DIABETES MELLITUS. THE PATIENT HAD STARTED ANTICOAGULATION THERAPY IN DECEMBER, 1990. USING THE COUMATRAK DEVICE IN THE OFFICE, THE PHYSICIAN OBTAINED A PROTHROMBIN TIME MEASUREMENT OF 27 SECONDS ON 7/29/92. THE PHYSICIAN IMMEDIATELY STOPPRD THE COUMADIN (DAILY DOSAGE OF 7.5 MG) WITH INSTRUCTIONS TO THE PATIENT TO RESTART THERAPY AT 5 MG DAILY THREE DAYS LATER (7/31/92).THE PATIENT WAS ADMITTED TO THE HOSPITAL TWO DAYS AFTER EVALUATION WITH A "STROKE AFTER THROWING A CLOT." PROTHROMBIN TIME MEASURED IN THE EMERGENCY ROOM WAS 11 SECONDSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUMATRAK PROTHROMBIN TIME (PT) TEST GJS BIOTRAK, INC. REA. CART; P10213

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other