BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1457399 · Received June 24, 2009

    Report

    Report Number
    2027969-2009-00479
    Event Type
    Malfunction
    Date Received
    June 24, 2009
    Date of Event
    May 27, 2009
    Report Date
    June 23, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED: DATE:(B)(6)2009, INRATIO: 2.5, REFERENCE: 2.1, MEAN: 2.30, CONFIDENCE LIMITS: 1.6-3.4. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB 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. FUNCTIONAL TESTING IS NOT REQUIRED AT THIS TIME. AS OF TODAY, NO PRODUCT IS EXPECTED TO RETURN. NO FURTHER INVESTIGATION WILL BE REQUIRED. PATIENT INFORMATION WAS NOT KNOWN. MEAN CALCULATION REVEALED BOTH INRATIO AND LAB 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. FURTHER TESTING IS NOT REQUIRED AT THIS TIME. PRODUCT DEFICIENCY COULD NOT BE ESTABLISHED. TRENDING AND TRACKING WILL BE PERFORMED IN REVIEW FOR STRIP LOT#213039. NO CORRECTIVE ACTION IS REQUIRED AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6)2009, INRATIO: 2.5, LAB: 2.1. CALLER BROUGHT METER TO DOCTOR'S OFFICE AN DID THE COMPARISON. NO REPEAT WAS DONE ON INRATIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0100071 213039

    Patients

    Seq Age Sex Outcome Treatment
    1 NI