BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTIME 3 CUVETTE ASSAY

    MDR report key: 2994354 · Received March 5, 2013

    Report

    Report Number
    2248721-2013-00012
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 5, 2013
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    GJS
    PMA / PMN Number
    K010599
    Removal / Correction Number
    2248721-09/19/12-001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED ON (B)(4) 2013 REFERENCE ITC COMPLAINT (B)(4). MFR NOTIFIED FDA ON (B)(4) 2012 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 MFG PROCESS, QC, AND PRODUCT SURVEILLANCE PARAMETERS AS CONTRIBUTORY TO THE UNDER RECOVERY AND INCONSISTENT RESULTS ARE NOW BEING CONTROLLED SUCH THAT ALL FUTURE PRODUCT MEETS ALL SPEC WITH MINIMIZED VARIABILITY AND BIAS TO ENSURE CLINICAL EQUIVALENCY TO INR REFERENCE STANDARDS. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    PT SELF-TESTER REPORTS LOWER THAN EXPECTED RESULTS WITH THE PROTIME MICROCOAGULATION SYSTEM. PT REPORTED TESTING WITH A RECALLED LOT OF PROTIME3 CUVETTES AND WAS GENERATING RESULTS OF APPROX 1.7 INR. UPON INCREASING HER COUMADIN DOSE, INR REMAINED LOWER THAN EXPECTED. PT WENT TO THE EMERGENCY ROOM TO HAVE A LAB TEST PERFORMED AND SHE WAS EXPERIENCING A BAD HEADACHE, TINGLING, AND NAUSEA. INR AT THE HOSPITAL WAS 7.0INR. PT WAS ADMITTED TO THE HOSPITAL OVERNIGHT FOR OBSERVATION AND TO RUN ADD'L TESTS. AT THE TIME OF THIS REPORT, CUSTOMER STATED SHE FEELS BETTER NOW. PT'S THERAPEUTIC RANGE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93039 PROTIME 3 CUVETTE ASSAY GJS INTERNATIONAL TECHNIDYNE CORPORATION B2K3H033

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R