BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTIME 3 CUVETTE ASSAY

    MDR report key: 2841909 · Received November 14, 2012

    Report

    Report Number
    2248721-2012-00134
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    March 1, 2012
    Report Date
    October 18, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GJS
    PMA / PMN Number
    K010599
    Removal / Correction Number
    2248721-09/19/2012-001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD CODE: ACTUAL DEVICE NOT EVALUATED (CUVETTE/SINGLE-USE DISPOSABLE). RESULT: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: INCONCLUSIVE -INVESTIGATION IS PROGRESS. MANUFACTURER NOTIFIED FDA ON (B)(4) OF PROTIME 3 CUVETTES VOLUNTARY RECALL. PROTIME 3 CUVETTES WITHIN A SPECIFIED LOT RANGE MAY RECOVER LOWER THAN EXPECTED PROTHROMBIN TIME/INTERNATIONAL NORMALIZED RATIO (PT/INR) RESULTS. ITC'S INVESTIGATION INTO THE PRODUCT'S PERFORMANCE IDENTIFIED INCREASED IMPRECISION IN ADDITION TO AN INCREASED NEGATIVE BIAS CORRESPONDING TO MANUFACTURING CHANGES.

    Description of Event or Problem · 1

    PATIENT SELF-TESTER REPORTS HOSPITAL ADMISSION FOR GASTROINTESTINAL (GI) BLEED WITH SUBSEQUENT BLOOD TRANSFUSIONS TO TREAT ANEMIA. PATIENT INDICATED FOR SEVERAL MONTHS, HER INR RESULTS WITH THE PROTIME MICROCOAGULATION SYSTEM HAVE BEEN LOWER THAN EXPECTED AND SHE HAS BEEN INCREASING HER COUMADIN DOSES PER HER PHYSICIAN. PATIENT'S THERAPEUTIC RANGE WAS NOT PROVIDED. ON (B)(6) 2012, PATIENT OBSERVED BLOOD IN HER STOOL AND BLEEDING GUMS. PATIENT TESTED WITH PROTIME, GENERATING INR OF 9. DUE TO THIS SUPRA-THERAPEUTIC INR, PATIENT STOPPED TAKING COUMADIN. FOUR DAYS LATER, ON (B)(6) 2012, PATIENT WAS ADMITTED TO THE HOSPITAL WITH GI BLEED AND ANEMIA. INR RESULT AT THE HOSPITAL WAS 2.4 INR. PATIENT HAD BLOOD TRANSFUSIONS, RECEIVING 5 UNITS OF RED BLOODS CELLS ON (B)(6) 2012, AND AN ADDITIONAL 2 UNITS ON (B)(6) 2012. PATIENT'S DIAGNOSIS AT THE HOSPITAL WAS HIATAL HERNIA, GASTRITIS, DIVERTICULITIS, INTERNAL HEMORRHOIDS, PROCTITIS, AND SHE WAS SUPRA-THERAPEUTIC FOR COUMADIN PER THE INR OF 9 GENERATED WITH PROTIME. THE BLEEDING WAS REVERSED AND PATIENT WAS INSTRUCTED TO RESUME COUMADIN THERAPY UPON HOSPITAL DISCHARGE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME 3 CUVETTE ASSAY GJS INTERNATIONAL TECHNIDYNE CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R