BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1612232 · Received February 4, 2010

    Report

    Report Number
    2027969-2010-00139
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    January 7, 2010
    Report Date
    February 4, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 1.3, REFERENCE: 3.42, MEAN: 2.36, CONFIDENCE LIMITS 1.4-3.1. DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH INRATIO AND LAB VALUES WERE OUTSIDE OF THE CONFIDENCE LIMITS FOR INR TESTING. TROUBLESHOOTING OF THE INVESTIGATION REVEALED DOUBLE DROPS OF SAMPLE WAS APPLIED TO THE TEST. THIS TECHNIQUE MAY HAVE AFFECTED TEST RESULTS. ACCURACY TESTING WAS PERFORMED ON RETAINED STRIP LOT #223042 THAT IS ASSOCIATED WITH REPORTED STRIP CODE BA7JS. TEST RESULTS INDICATED NO STRIP DEFICIENCY. AS OF 02/03/2010, THREE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #223042 YIELDING A COMPLAINT RATE OF 0.002%. 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FOR RETAINED LOT #223042 WITH CODE BA7JS: THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT 223042 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER INVESTIGATION WILL BE PURSUED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: 1.3, LAB: 3.42.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 223042

    Patients

    Seq Age Sex Outcome Treatment
    1 NI