BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2022519 · Received February 15, 2011

    Report

    Report Number
    2027969-2011-00330
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: DATE: (B)(6) 2011, INRATIO METER = 7.5, REFERENCE = 3.0, MEAN = 5.25, CONFIDENCE LIMITS = NA. THE MEAN IS >5.0 AND THE DIFFERENCE IS GREATER THAN 2.2. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. ADD'L INVESTIGATION IS REQUIRED. PREVIOUS INVESTIGATION ON STRIP LOT 242425 FROM ANOTHER COMPLAINT MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. TWO THERAPEUTIC DONORS WERE TESTED USING RETAINED STRIPS, IN-HOUSE AND REFERENCE METERS. INVESTIGATION DETAILS: ACCURACY. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WERE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 242425 WERE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA; NO FURTHER INVESTIGATION IS REQUIRED. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4), 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:" DATE: (B)(6) 2011, INRATIO: 7.5, LAB: 3.0. SAMPLE WAS DRAWN AND SENT TO PATHOLOGY LAB. RESULT CAME BACK ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS099007EU 242425

    Patients

    Seq Age Sex Outcome Treatment
    1