BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUMATRAK PROTHROMBIN TIME (PT) TEST MONITOR

    MDR report key: 1699 · Received October 15, 1992

    Report

    Report Number
    33269-1992-00001
    Event Type
    Injury
    Date Received
    October 15, 1992
    Date of Event
    May 23, 1992
    Report Date
    September 25, 1992
    Manufacturer
    BIOTRAK, INC.
    Product Code
    GJS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT (MW) IS A 38 YEAR OLD FEMALE WHO HAD MITRAL VALVE REPLACEMENT ON 3-JAN-1983. A NURSE REPORTED THAT THE PATIENT WAS USING A COUMATRAK MONITOR AT HOME TO REGULATE HER COUMADIN DOSAGE ACCORDING TO HER PT (PROTHROMBIN TIME). HER PT RANGED FROM 17.8 AND 17.9 SECONDS BETWEEN 18- AND 20- MAY - 92 AT WHICH TIME SHE WAS TAKING COUMADIN 5 MG QD. FOR THE NEXT THREE DAYS (20- TO 22-MAY-92), THE PATIENT DOUBLED HER COUMADIN DOSAGE TO 10 MG QD AND DID NOT MONITOR HER PT. ON 23-MAY-92, SHE TASTED BLOOD IN HER THROAT AND CHECKED HER PT, WHICH WAS 43 SECONDS. THE PATIENT DID NOT TAKE ANY COUMADIN AFTER 22-MAY-92. ON 26 MAY 92, SHE CALLED HER PHYSICIAN AND WAS ADMITTED TO THE HOSPITAL, WHERE PT WAS 77 SECONDS. SHE WAS REPORTED TO HAVE A NUMBER OF HEMOTOMAS ON HER BACK AND ON THE BACK OF HER LEGS. THESE WERE DESCRIBED AS BEING "A MESS, ECCHYMOTIC." WHILE THE PATIENT WAS IN THE HOSPITAL, THE NURSE RAN A PT ON THE PATIENT'S MONITOR AND GOT A READING OF 17.4 SECONDS (SERUM PT, 18 SECONDS). USING THE OFFICE MONITOR AND A SECOND DROP OF BLOOD FROM THE SAME STICK, THE PATIENT'S PT WAS 15.7 SECONDS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON 1-JUN-92. COUMADIN DOSAGE WAS REDUCED. PHYSICIAN SUSPECTED THE ADVERSE EVENT OCCURRED DUE TO INACCURATE PT MEASUREMENTS BY THE COUMATRAK MACHINEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. 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 MONITOR GJS BIOTRAK, INC. P00233

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention