BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1555807 · Received November 24, 2009

    Report

    Report Number
    2027969-2009-01098
    Event Type
    Injury
    Date Received
    November 24, 2009
    Date of Event
    October 30, 2009
    Report Date
    November 24, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS PERFORMED ON INR RESULTS PROVIDED BY THE CUSTOMER. THE 1.8 INR IS EXCLUDED FROM COMPARISON TEST SINCE NO LAB REFERENCE INDICATED AND IS OBTAINED MORE THAN 3 HOURS FROM PREVIOUS RESULT (5.5 INR). SINCE TIME OF TEST EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2009, INRATIO METER: 5.5 INR, REFERENCE: 3.9 INR, MEAN: 4.70, CONFIDENCE LIMITS: 2.6 - 6.9. 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. METER WAS RETURNED; FUNCTIONAL TEST WAS PERFORMED ON RETURNED METER. ALL TESTING CRITERIA PASSED. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. FURTHER TEST IS NOT REQUIRED AT THIS TIME. TRENDING AND TRACKING WILL BE PERFORMED IN REVIEW FOR STRIP LOT # 220375. (TOTAL NUMBER OF DISCREPANT COMPLAINTS, INCLUDING THIS EVENT, IS 3). THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND LAB INRS ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 220375 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DISCREPANCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: "DATE: 2009. INRATIO: 5.5, LAB: 3.9. PATIENT REPORTS THAT SHE HAS ALWAYS RECEIVED HIGH RESULTS FROM THE METER. SHE HAS HAD IT FOR JUST A FEW WEEKS. A 5.5 ON THE METER AND WITHIN 30 MINUTES 3.9 AT THE HOSPITAL LAB, HER RANGE IS AROUND 2.5 AND A DOSE WAS WITHHELD, SHE TESTED TODAY AND GOT A 1.8. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100071 220375

    Patients

    Seq Age Sex Outcome Treatment
    1 Other