BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1332433 · Received February 26, 2009

    Report

    Report Number
    2027969-2009-00060
    Event Type
    Injury
    Date Received
    February 26, 2009
    Date of Event
    February 4, 2009
    Report Date
    February 26, 2009
    Manufacturer
    BIOSITE, INC
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS REPORTABLE BECAUSE A RECURRENCE MAY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME OF COMPLAINT WAS REVIEWED: INRATIO: 1.5, LAB: 6.5, MEAN: 4.0, CONFIDENCE LIMITS: 2.3-5.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES FALL OUTSIDE THE CONFIDENCE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. INRATIO PRECISION DATA PROVIDED BY END-USER LOT (INRATIO METER): 1ST INR = 1.9, 2ND INR = 2.0, MEAN: 2.0, SD: 0.1, %CV: 3.6. THE 3.6% CV IS LESS THAN 20%. INRATIO METER RESULTS PASSES THE CRITERIA FOR PRECISION. DEVICE IS NOT BEING RETURNED BACK FOR EVAL.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2009, INRATIO: 1.5. IN THE NEXT DAY, LAB: 6.5. PT RECEIVED 6 QUARTS OF BLOOD IN HOSPITAL IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE, INC 0100007

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization