BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3770345 · Received March 7, 2014

    Report

    Report Number
    2027969-2014-00200
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNED FOR EVAL. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, RETAIN TESTING WAS PERFORMED DURING AN IN-HOUSE INVESTIGATION. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MFG RECORDS FOR THE LOT WERE REVIEWED. THE NON-CONFORMANCE ASSOCIATED WITH THIS LOT WAS NOT RELEVANT TO THE INITIAL COMPLAINT AND DOES NOT AFFECT PRODUCT PERFORMANCE. NO FURTHER INVESTIGATION WAS PERFORMED. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE REFERENCE METER. RESULTS AS FOLLOWS:" DATE: (B)(6) 2014, INRATIO: 1.5, POC METER: 2.6. TIME BETWEEN TESTS: WITHIN 5 MINUTES THERAPEUTIC RANGE: 2.0-3.0 PATIENT SELF- TESTER WAS MILKING FINGER AFTER FINGER STICK. PT SELF-TESTER HAS A PORT AND IT WAS FLUSHED WITH HEPARIN ON TUESDAY (B)(6) 2014; HIS WIFE INFORMED TECH SERVICE REP THAT IT IS A VERY SMALL AMOUNT OF HEPARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140167 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 332831

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN| PT SELF TESTER HAD PORT FLUSHED WITH HEPARIN