BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2682308 · Received August 1, 2012

    Report

    Report Number
    2027969-2012-01147
    Event Type
    Malfunction
    Date Received
    August 1, 2012
    Date of Event
    July 3, 2012
    Report Date
    August 1, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: COMPARISON OF INRATIO TEST RESULT(S) WITH LAB RESULT(S) PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2012, INRATIO: (1.0), LAB: 2.7, MEAN: 1.85, CONFIDENCE LIMITS: (1.2 - 2.3), RESULT: FAIL. REPORTED RESULTS ARE OUTSIDE OF DETERMINED CONFIDENCE LIMITS FOR PASSING ACCURACY COMPARISON. CRITERIA FOR TESTING ACCURACY HAS FAILED, AND VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. FURTHER TESTING IS REQUIRED. NO PRODUCT ASSOCIATED WITH THE COMPLAINT IS EXPECTED FOR RETURN. IN-HOUSE THERAPEUTIC DONOR TESTING WITH RETAIN STRIPS WAS PERFORMED WITH REPORTED LOT NUMBER 262184. TEST RESULTS AS FOLLOWS: DONOR 1, INRATIO RESULTS: (3.2, 3.4, 3.0), REFERENCE: 2.63, BIAS THRESHOLD: (1.63 - 3.63), %CV: 6.25. DONOR 2, INRATIO RESULTS: (3.8, 3.6, 4.0), REFERENCE: 3.13, BIAS THRESHOLD: (2.13 - 4.13), %CV: 5.26. ALL REPLICATES FOR THE EACH DONOR ARE WITHIN ACCEPTABLE BIAS FOR ACCURACY. EACH DONOR PRODUCED %CV LESS THAN 16%. PRECISION CRITERIA HAS BEEN MET. PRODUCT PERFORMED AS EXPECTED. NO FURTHER INVESTIGATION IS NECESSARY. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTS REVEALED THAT TEST RESULTS DID NOT MEET PRECISION CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED, REVIEW OF RECENT IN-HOUSE THERAPEUTIC SAMPLE TESTING REVEALED THAT RETAIN STRIPS MET ACCURACY AND PRECISION CRITERIA. AS REVIEWED ON (B)(4) 2012, (B)(4). DUE TO INCREASE IN DISCREPANT COMPLAINTS WITH INRATIO STRIPS, THIS ISSUE WAS ESCALATED TO CAPA (B)(4).

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH THE INRATIO METER. CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO METER COMPARED TO POINT OF CARE (POC) METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO RESULTS: 1.0, POC: 2.7. RESULTS WERE ONE MIN A PART. PT'S THERAPEUTIC RANGE: 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 262184

    Patients

    Seq Age Sex Outcome Treatment
    1