BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2211244 · Received July 11, 2011

    Report

    Report Number
    2027969-2011-01515
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: DATE: (B)(6) 2011, INRATIO: >7.5 INR, REFERENCE: 4.7 INR. THE INRATIO >7.5 AND COMPARATIVE SYSTEM LESS THAN 5.0. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. ADDITIONAL INVESTIGATION IS REQUIRED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 5.0 INR, REFERENCE: 4.7 INR, MEAN: 4.85, CONFIDENCE LIMIT: 2.6 - 6.9. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. RECENT TEST CONDUCTED ON LOT 253023 ON (B)(4) 2011 MET ACCURACY CRITERIA. (B)(4). NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT ONE OUT OF TOTAL TWO TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION CUSTOMER PROVIDED. PT'S MEDICATIONS/CONDITION COULD NOT BE RULED OUT. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. (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. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 5.0, INRATIO: >7.5, LAB: 4.7. THE >7.5 RESULT AND LAB RESULT WERE DONE 5 MINUTES APART. THE 5.0 RESULT WAS DONE BY THE PT AT AN UNSPECIFIED TIME PRIOR TO GOING TO THE LAB. PT'S TARGET THERAPEUTIC RANGE IS 2.0 - 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253023

    Patients

    Seq Age Sex Outcome Treatment
    1