BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2688042 · Received November 19, 2007

    Report

    Report Number
    2954730-2007-00575
    Event Type
    Malfunction
    Date Received
    November 19, 2007
    Date of Event
    November 2, 2007
    Report Date
    November 15, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: STRIP LOT #: 070454; DATE: (B)(6) 2007; INRATIO: 2.5; LAB: 2.89; MEAN: 2.70; CONFIDENCE LIMITS: 1.7 - 3.8. DATE: (B)(6) 2007; INRATIO: 1.5; LAB: 3.95; MEAN: 2.73; CONFIDENCE LIMITS: 1.7 - 3.8. STRIP LOT # 070281. PER INTERNAL PROCEDURE, TR 0150, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE 1ST, 5TH, 6TH, AND 7TH DATA SET, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. FOR THE 2ND, 3RD, AND 4TH DATA SET, BOTH INRATIO AND LAB VALUES ARE NOT WITHIN THE CONFIDENCE LIMITS. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE FURTHER TESTING IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: STRIP LOT# 207454; DATE: (B)(6) 2007; INRATIO: 2.5; LAB: 2.89. DATE: (B)(6) 2007; INRATIO: 1.5; LAB: 3.95. STRIP LOT # 070281.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS HEMOSENSE, INC. 070281

    Patients

    Seq Age Sex Outcome Treatment
    1