BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1442860 · Received May 20, 2009

    Report

    Report Number
    2027969-2009-00343
    Event Type
    Malfunction
    Date Received
    May 20, 2009
    Date of Event
    April 22, 2009
    Report Date
    May 20, 2009
    Manufacturer
    BIOSITE, INC.
    Product Code
    JPA
    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 TIME COMPLAINT WAS FILED: DATE: 2009; INRATIO: 3.8; LAB: 2.5; MEAN: 3.15; CONFIDENCE LIMITS: 1.9-4.6. DATE: SAME DAY; INRATIO: 3.4; LAB: 2.8; MEAN: 3.10; CONFIDENCE LIMITS: 1.9-4.6. 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. DEVICE WAS NOT RETURNED FOR EVALUATION. NO FURTHER INVESTIGATION WILL BE REQUIRED. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF FUTURE CORRECTIVE ACTION IS WARRANTED. AS OF THE FOLLOWING DAY, 25 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT #080584 YIELDING A COMPLAINT RATE OF 0.005%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION IS REQUIRED AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH INRATIO METERS VERSUS LAB. PT 1: INRATIO: 3.8; LAB: 2.5. PT 2: INRATIO: 3.4; LAB: 2.8. RESULTS ARE FROM TWO DIFFERENT PTS. NO REPEAT TEST WAS PERFORMED. BLOOD FOR LAB WAS DRAWN WITHIN 10 MINS OF INRATIO TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE, INC. 0100139

    Patients

    Seq Age Sex Outcome Treatment
    1 NI