BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2102606 · Received May 20, 2011

    Report

    Report Number
    2027969-2011-01123
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST RESULT(S) WITH LAB RESULT(S) PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 3.0, REFERENCE: 2.4, MEAN: 2.7, CONFIDENCE LIMIT: 1.7 - 3.8, RESULT: PASS. REPORTED RESULTS ARE WITHIN THE CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 247451 ON (B)(4) 2011. RESULTS AS FOLLOWS: INRATIO: 1.6, INRATIO: 1.6, INRATIO: 1.6, REFERENCE: 1.64, BIAS THRESHOLD: 1.14 - 2.14; 2.7, 2.8, 2.7, 2.44, 1.44 - 3.44. THE MINIMUM TWO OUT OF THREE REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. METER IS EXPECTED TO BE RETURNED AND WILL BE INVESTIGATED WHEN REC'D. (B)(4). ACTION THRESHOLD (B)(4) HAS REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE 62935 WHICH BRICK LOT NUMBER 237418 WAS ASSIGNED AND PACKAGED INTO TWO STRIP LOTS (247450 AND 247451). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF (B)(4). CORRECTIVE ACTION IS NOT 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: 3.0, LAB: 2.4, TARGET RANGE IS 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1