BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1573871 · Received December 16, 2009

    Report

    Report Number
    2027969-2009-01184
    Event Type
    Malfunction
    Date Received
    December 16, 2009
    Date of Event
    November 23, 2009
    Report Date
    December 16, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6)2009, INRATIO: 3.1, REF.:2.9, MEAN: 3.00, CONFIDENCE LIMITS: 1.8-4.2. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. CUSTOMER RESULTS ANALYZED AND ACCURACY CONFIDENCE LIMITS WERE MET. PRODUCT DEFICIENCY NOT ESTABLISHED. FURTHER INVESTIGATION NOT REQUIRED. AS OF (B)(6)2009, 2 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #221726. TRENDING AND TRACKING WILL BE DONE IN REVIEW. CORRECTIVE ACTION IS NOT REQUIRED AS PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6)2009, INRATIO: 3.1, DOCTOR'S METER (DIFFERENT BRAND): 2.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 221726

    Patients

    Seq Age Sex Outcome Treatment
    1