BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUMATRAK PROTIME TEST SYSTEM

    MDR report key: 21250 · Received February 13, 1995

    Report

    Report Number
    1054435-1995-00010
    Event Type
    Injury
    Date Received
    February 13, 1995
    Date of Event
    January 19, 1995
    Report Date
    February 9, 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 REPORTED THAT A PTBEGAN COUMADIN IN JUL, 1994 FOLLOWING A CVA (CEREBROVASCULAR ACCIDENT). ON 1/3/95, HIS DOSAGE WAS 7.5 MG QD ALTERNATING WITH 10 MG QD. ON 1/9/95, COUMADIN DOSAGE WAS 10 MG QD. PT (PROTHROMBIN TIME) HAS BEEN STABLE AT 18.8-20.9. ON 1/16/95, PT WAS 23.1 USING A COUMATRAK PROTIME TEST SYSTEM IN THE PHYSICIAN'S OFFICE. COUMADIN DOSAGE WAS NOT CHANGED. ON 1/19/95, THE PT RETURNED TO THE PHYSICIAN'S OFFICE BECAUSE HE FELT ILL AND HAD NOTICED HIS STOOL BECOMING DARKERAND 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 1/19/95, THE PT WAS HOSPITALIZED WITH A GI (GASTROINSTESTINAL) BLEED. HGB (HEMOGLOBIN) WAS NOTED TO BE 11.4. THE LAST PT EVALUATED ON 1/19/95 HAD A PT OF 15.6 USING THE COUMATRAK MONITOR. THE NURSE FELT THE COUMATRAK MONITOR WAS NOT ACCUTEE. PROPER TECHNIQUE AND USE OF CONTROLS WERE CONFIRMED. THE NURSE NOTED THAT AN ORIGINAL MONITOR HAD BEEN REPLACED ON 1/13/95. THE CUURENT REPORT CONCERNS THE REPLACEMENT MONITORR WHICH WILL BE RETURNED TO THE MANUFACTURER.

    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 UMADIN 7/94/UNKNOWN CARDIZEM| PRILOSEC| ASPIRIN VASOTEC