BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1589227 · Received January 15, 2010

    Report

    Report Number
    2027969-2010-00044
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 16, 2009
    Report Date
    January 15, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: INRATIO: 1.3; REFERENCE: 4.0; MEAN: 2.65; CONFIDENCE-LIMITS: 1.7-3.8. INRATIO: 1.5; REFERENCE: 2.1; MEAN: 1.80; CONFIDENCE-LIMITS: 1.2-2.3. MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED ACCURACY CRITERIA WAS NOT MET. IN-HOUSE REPLICATION TESTING WITH RETURNED METER DID NOT REPRODUCE CUSTOMER'S OBSERVATION. METER FUNCTIONAL TEST RESULTS DID NOT INDICATE PRODUCT DEFICIENCY. PT CONDITIONS MAY HAVE AFFECTED INRATIO TEST RESULTS. IT WAS INDICATED THAT THE PT IS DIABETIC. AS OF 01/14/2010, FOUR DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #221727 YIELDING A COMPLAINT RATE OF 0.001%. 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 IS REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS ON UNIT (B)(4) AND RETAINED STRIP LOT 221727. 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 221727 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6)2009, INRATIO: 1.3, LAB: 4.0; 1.5, 2.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 221727

    Patients

    Seq Age Sex Outcome Treatment
    1 NI