BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1544802 · Received November 4, 2009

    Report

    Report Number
    2027969-2009-01003
    Event Type
    Malfunction
    Date Received
    November 4, 2009
    Date of Event
    October 15, 2009
    Report Date
    November 4, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY). COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. REFERENCE VALUE ON TEST 2 FALLS OUTSIDE LIMITS, SO THE CRITERIA IS NOT MET AND THE VALUE IS DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIPS ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH REFERENCE VALUE ON TEST-2 WAS OUTSIDE OF THE HIGHER CONFIDENCE LIMIT FOR INR TESTING. METER AND STRIPS WERE NOT EXPECTED TO BE RETURNED. RETAIN STRIP TESTS WERE PERFORMED. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. THERE IS NOT SUFFICIENT INFO TO DETERMINE THE ROOT CAUSE OF END-USER'S DISCREPANCY. FURTHER TEST IS NOT REQUIRED AT THIS TIME. AS OF 10/26/2009, 14 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #213040 YIELDING A COMPLAINT RATE OF 0.004%. DUE TO THE 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.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2009. INRATIO: 1.4. LAB: 2.6. POC METER: 2.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 0100139 213040

    Patients

    Seq Age Sex Outcome Treatment
    1 NI