BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2615819 · Received June 12, 2012

    Report

    Report Number
    2027969-2012-00897
    Event Type
    Malfunction
    Date Received
    June 12, 2012
    Date of Event
    May 15, 2012
    Report Date
    June 12, 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

    THE 510K NUMBER LISTED IS FOR THE INRATIO (ORIGINAL); THE 510K NUMBER FOR THE INRATIO2 IS K072727. DISCREPANT RESULTS (PRECISION) COMPARISON OF INRATIO TEST RESULTS AS FOLLOWS: DATE: (B)(4) 2012, INRATIO: 7.5, INRATIO: 6.1, MEAN: *, SD: *, %CV: *, RESULT: *; (B)(4) 2012, 6.2, 3.8, 5.0, 1.70, 33.94, FAIL. REPORTED RESULTS PRODUCED %CV GREATER THAN 20%. INRATIO METER RESULTS FAIL THE CRITERIA FOR PRECISION. THE RESULTS ARE CONSIDERED DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. NO STRIP LOT INFORMATION PROVIDED. NO PRODUCT ASSOCIATED WITH THE COMPLAINT IS EXPECTED FOR RETURN. NO FURTHER INVESTIGATION IS POSSIBLE. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTS REVEALED THAT TEST RESULTS DID NOT MEET PRECISION CRITERIA. NO LAB REFERENCE TESTING HAS BEEN REPORTED. ROOT CAUSE COULD NOT BE DETERMINED. NO STRIP LOT INFORMATION WAS AVAILABLE AND NO PRODUCT WAS EXPECTED TO BE RETURNED, FURTHER INVESTIGATION FOR PRODUCT PERFORMANCE COULD NOT BE PERFORMED. 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

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" (B)(6) 2012-INRATIO (ORIGINAL) INR=7.5, INRATIO 2 INR=6.1; (B)(6) 2012-INRATIO (ORIGINAL) INR=6.2, INRATIO 2 INR=3.8. TESTS PERFORMED WITHIN 15 MIN. OF EACH OTHER. DIFFERENT FINGER USED FOR EACH TEST. CALLER DID NOT HAVE PATIENT'S INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1