BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1446138 · Received May 21, 2009

    Report

    Report Number
    2027969-2009-00349
    Event Type
    Malfunction
    Date Received
    May 21, 2009
    Date of Event
    April 23, 2009
    Report Date
    May 21, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULT (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: TEST 1; METER: 4.2; LAB: 3.1; MEAN: 3.65; CONFIDENCE LIMITS: 2.2-5.3. CALLER REPORTED THAT THE LAB TEST WAS PERFORMED ON THE SAME DAY AS THE METER TEST. TIME ELAPSED BETWEEN BOTH TESTS WAS NOT GIVEN. IF THE TIME ELAPSED EXCEEDS 3 HOURS; THEN THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE INR 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. PRODUCT TESTING IS NOT REQUIRED. DEVICE WAS NOT RETURNED FOR EVAL. FURTHER TESTING IS NOT REQUIRED AT THIS TIME. PRODUCT DEFICIENCY COULD NOT BE ESTABLISHED. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF FUTURE CORRECTIVE ACTION IS WARRANTED. AS OF DATE, 10 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT# 080818 YIELDING A COMPLAINT RATE OF 0.003%. 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 VERSUS LAB. INRATIO: 4.2; LAB: 3.1. CALLER STATED THAT THERE HAS NOT BEEN ANY HEPARIN, LMWH OR OTHER MEDICATION CHANGES. NOR ANY CHANGE IN DIET, AND NO SYMPTOMS OF BLEEDING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI