BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 686920 · Received March 9, 2006

    Report

    Report Number
    2954730-2006-00085
    Event Type
    Malfunction
    Date Received
    March 9, 2006
    Date of Event
    February 1, 2006
    Report Date
    March 7, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY). COMPARISON OFINRATION WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE 2006, INRATIO 2.1, LAB 8.9, MEAN NA, CONFIDENCE LIMITS NA. PER INTERNAL PROCEDURE, TR 0150, IN CASES WHERE THE COMPARATIVE SYSTEM HAS AN INR VALVE GREATER THAN THE LIMIT OF DETECTION AND THE INRATION VALUE IS LESS THAN 5.0, THE RESULTS ARE CONSIDERED INACCURATE AND FURTHER TESTING IS REQUIRED. RESULTS OF TESTS PERFORMED ABOUT ONE MONTH LATER: PER PR 0103, IN-HOUSE RETAINS WERE TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. THE ACCEPTANCE CRITERIA IS AS FOLLOWS: IF THE MLA INR IS LESS THAN 2.0, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE MLA INR SHALL BE +/-0.5. IF THE MLA INR IS 2.0 - 4.5, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE MLA INR SHALL BE +/-1.0. PATIENT 1 LOT 050595 RETAINS 2.8, MLA INR 2.7, DIFFERENCE (0.1), RESULT PASS. PATIENT 1 LOT 050595 RETAINS 2.8, MLA INR 2.7, DIFFERENCE (0.1), RSULT PASS. PATIENT 1 LOT 50595 RETAINS 3.0, MLA INR 2.7, DIFFERENCE (0.3), RESULT PASS. PATIENT 2 LOT 050595 RETAINS 3.0, MLA INR 2.7, DIFFERENCE (0.3) RESULT PASS. PATIENT 2 LOT 050595 RETAINS 2.8, MLA INR 2.7, DIFFERENCE (0.1) RESULT PASS. PATIENT 2 LOT 050595 3.0, MLA INR 2.7, DIFFERENCE (0.3), RESULT PASS. A REVIEW OF THE DHR REVEALED NO MANUFACTURING ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE ALLEGED FAILURE. STRIP LOT 050595 IS CONSIDERED ACCURATE BASED ON THE ABOVE TEST RESULTS.

    Description of Event or Problem · 1

    THE CALLER ALLEGED RESULTS WHEN COMPARED WITH THE LAB. THE FOLLOWING RESULTS WERE REPORTED. 1/2006 INRATIO 2.1, LAB 8.9(ONE HOUR LATER) COUMADIN DOSE HELD BASED ON LAB READING, 2/2006 INRATIO 2.3, LAB NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB. THE FOLLOWING RESULTS WERE REPORTED.: 2006 INRATIO 2.1, LAB 8.9 (ONE HOUR LATER) COUMADIN DOSE HELD BASED ON LAB READING. TWO DAYS LATER; 2.3, NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050595

    Patients

    Seq Age Sex Outcome Treatment
    1 *