BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2070810 · Received April 15, 2011

    Report

    Report Number
    2027969-2011-00833
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: NG, INRATIO: 3.3, ROCHE: 2.6, MEAN: 2.67, CONFIDENCE LIMITS: 1.7 - 3.8. WHO BIAS: NA, RESULT: PASS. DATE: NG, INRATIO: 2.7, ROCHE: 2.3, REF: 2.1, MEAN: 2.37, CONFIDENCE LIMITS: 1.4 - 3.1. WHO BIAS: 28.57, RESULT: PASS. REPORTED RESULTS ARE WITHIN THE CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON (BOTH ALERE AND WHO BIAS LIMITS). THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. (B)(4). THIS IS BELOW THE ACTION THRESHOLD OF (B)(4). CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, TIME: 8:30AM, INRATIO: 3.3, COAGUCHECK: 2.6. NURSE REMOVED THE FIRST DROP OF BLOOD THEN USED THE SAME FINGER STICK TO TEST BOTH INSTRUMENTS. DATE: (B)(6) 2011, INRATIO: 2.7, COAGUCHECK: 2.3, LAB: 2.1. ALL SAMPLES TAKEN AT THE SAME TIME, SEPARATE FINGER STICKS ON SEPARATE FINGERS FOR INRATIO AND COAGUCHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC HS0100139 249150

    Patients

    Seq Age Sex Outcome Treatment
    1