BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUMATRAK PROTIME TEST SYSTEM

    MDR report key: 22407 · Received February 9, 1995

    Report

    Report Number
    1823260-1995-00010
    Event Type
    Injury
    Date Received
    February 9, 1995
    Date of Event
    January 19, 1995
    Report Date
    January 26, 1995
    Manufacturer
    BOEHRINGER MANNHEIM CORPORATION-FREEMONT
    Product Code
    LOQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE REPORT THAT A PT BEGAN COUMADIN IN JUL-94 FOLLOWING A CVA (CEREBROVASCULAR ACCIDENT). ON 3-JAN-95, HIS DOSAGE WAS 7.5 MG QD ALTERNATING WITH 10MG QD. ON 9-JAN-95, COUMADIN DOSAGE WAS 10 MG QD. PT (PROTHROMBIN TI) HAD BEEN STABLE AT 18.8-20.9. ON 16-JAN-95, PT WAS 23.1 USING A COUMATRAK PROTIME TEST SYSTEM IN THE PHYSICIANS OFFICE (COUMATRAK MONITOR, THROMBOPLASTIN CARTRIDGE NUMBER). COUMADIN DOSAGE WAS NOT CHANGED. ON 19-JAN-95, THE PT RETURNED RETURNED TO THE PHYSICIAN'S OFFICE BECAUSE HE FELT ILL AND HAD NOTICED HIS STOOL BECOMING DARKER AND FINALLY BLACK. PT WAS 13.4 ON THE COUMATRAK MONITOR. A BLOOD SAMPLE WAS SENT TO A LABORATORY WHICH REPORTED A PT OF 26. ON THE EVENING OF 19-JAN-95, THE PT WAS HOSPITALIZED WITH A GI (GASTROINTESTINAL) BLEED. HGB (HEMOGLOBIN) WAS NOTED TO BE 11.4 THE LAST PT EVALUATED ON 19-JAN-95 HAD A PT OF 15.6 USING THE COUMATRAK MONITOR. THE FIRST PT EVALUATED ON 20-JAN-95 ALSO HAD A PT OF 15.6 THE NURSE FELT THE COUMATRAK MONITOR WAS NOT ACCURATE. PROPER TECHNIQUE AND USE OF CONTROLS WERE CONFIRMED. THE NURSE NOTED THAT AN ORIGINAL MONITOR HAD BEEN REPLACED ON 13-JAN-95. THE CURRENT REPORT CONCERNS THE REPLACEMENT MONITOR WHICH WILL BE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUMATRAK PROTIME TEST SYSTEM IN-VITRO HEMATOLOGY DEVICE LOQ BOEHRINGER MANNHEIM CORPORATION-FREEMONT NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R ASPRIN VASOTEC| COUMADIN JUL-94/UNKNOWN CARDIZEM