BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1739917 · Received June 23, 2010

    Report

    Report Number
    2027969-2010-00825
    Event Type
    Malfunction
    Date Received
    June 23, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 23, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT ALL RESULTS MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. AS OF 06/23/2010, FIVE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #225324 YIELDING A COMPLAINT RATE OF 0.009%. 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. AS OF 06/23/2010, TWO DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #233421 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. 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.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: STRIP LOT # 225324, DATE: (B)(6) 2010, INRATIO: 2.6, LAB: 3.3; 2.6, 5.1. FOLLOW UP WITH CUSTOMER WHO PERFORMED A CORRELATION USING REPLACEMENT STRIPS: STRIP LOT #233421: DATE: (B)(6) 2010, INRATIO: 3.6, LAB: 3.5; 3.6, 4.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 225324

    Patients

    Seq Age Sex Outcome Treatment
    1 NI