BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2391356 · Received December 13, 2011

    Report

    Report Number
    2027969-2011-02511
    Event Type
    Malfunction
    Date Received
    December 13, 2011
    Date of Event
    November 22, 2011
    Report Date
    December 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 FILLED: DATE (B)(4) 2011, INRATIO: 4.6 AND 3.1 INR, REFERENCE: 1.9 INR, MEAN: 3.2, CONFIDENCE LIMITS: 1.9 - 4.6. PRECISION TEST WAS PERFORMED ON INRATIO DATA (MEAN = 3.85, SD = 1.06, %CV = 27.55). SINCE %CV IS ABOVE 20%, TEST FAILED THE CRITERIA. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS 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 253026 ON (B)(4) 2011 MET ACCURACY AND PRECISION CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 145 = 2.6, 2.8, 2.7 INR: DONOR 146 = 3.6, 3.6, 3.6 INR. AT LEAST TWO OUT THREE REPLICATES ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) OF THE REFERENCE RESULTS FOR DONOR 145 (2.22 INR) AND DONOR 146 (3.1 INR), RESPECTIVELY. IN-HOUSE TEST RESULTS HAVE 3.7% AND 0%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. INVESTIGATION CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFO CUSTOMER PROVIDED. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAINED STRIP TEST RESULT COMPARISON MET ACCURACY AND PRECISION CRITERIA. THIRTY-FIVE DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT 253026 YIELDING A COMPLAINT RATE OF 0.008%. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED. 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: 4.6, RETEST INRATIO: 3.1, LAB: 1.9. COMPARISON DONE WITHIN 1 HOUR. PT'S TARGET THERAPEUTIC RANGE IS 2 - 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 253026

    Patients

    Seq Age Sex Outcome Treatment
    1