BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2272336 · Received August 26, 2011

    Report

    Report Number
    2027969-2011-01889
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    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: DATE: (B)(6) 2011, INRATIO: 1.2, REFERENCE: 7.0, MEAN: 4.10, CONFIDENCE LIMITS: 2.3 - 5.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. RECENT TEST CONDUCTED ON LOT 253025 ON 7/28/2011 MET ACCURACY CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 78 = 2.1, 1.7, 1.8 INR; DONOR 79 = 2.8, 2.9, 3.2 INR. AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (CHANGE TO + OR - 1.0) OF REFERENCE RESULTS FOR DONOR 78 (1.77 INR) AND DONOR 79 (2.95 INR), RESPECTIVELY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFO CUSTOMER PROVIDED. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. 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, NO FURTHER ACTION IS REQUIRED AT THIS TIME. 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: 1.2, LAB: 7.0. LAB DRAW WAS DONE WITHIN AN HR OF METER RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253025

    Patients

    Seq Age Sex Outcome Treatment
    1