BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1874227 · Received October 12, 2010

    Report

    Report Number
    2027969-2010-01685
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST RESULTS WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: UNKNOWN, INRATIO: 3.4, REFERENCE: 7.9, MEAN: 5.65. (B)(6) 2010: INRATIO: 1.6, REFERENCE: 3.8, MEAN: 2.7, CONFIDENCE LIMITS: 1.7-3.8, RESULT: FAIL. FOR FIRST SET OF RESULTS OBTAINED, USER REPORTED TWENTY-FOUR (24) HOURS INTERVAL BETWEEN TESTS FOR PATIENT RESULTS. A MAXIMUM OF THREE (3) HOURS IS DETERMINED REASONABLE FOR COMPARISON OF PT/INR RESULTS FROM BOTH POINT OF CARE AND LAB INSTRUMENTS. TIMING DISPARITIES GREATER THAN THIS HAVE AN INCREASED LIKELIHOOD OF FACTORS OTHER THAN THE INSTRUMENT INFLUENCING THE RESULTS. FOR THE SECOND SET OF REPORTED RESULTS, THE INRATIO VALVE EXCEEDS THE BOUNDS OF THE DETERMINED CONFIDENCE LIMITS. CRITERIA FOR TESTING ACCURACY HAS FAILED, AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. RETURN TESTING PERFORMED (B)(6) 2010 WITH PASSING RESULTS. INVESTIGATION DID NOT REPLICATE ORIGINAL REPORTED COMPLAINT. INVESTIGATION CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. STRIP LOT INFORMATION WAS NOT PROVIDED BY CUSTOMER. METER MEMORY REVIEWED AND REPORTED TEST VALUES VERIFIED. RETURNED METER WITH RETAIN STRIPS TEST DID NOT REPRODUCE CUSTOMER'S OBSERVATION. TEST RESULT COMPARISON MET ACCURACY AND PRECISION CRITERIA. ADDITIONAL INVESTIGATION FOR CHILD CASE WILL BE PERFORMED. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. THIS ISSUE WILL BE SUBJECTED TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. NO FURTHER REPORTS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT RESULTS WITH METER COMPARED TO LAB. DATE: "2 WEEKS AGO", INRATIO: 3.4. DATE: "24 HOURS LATER": LAB: 7.9. PATIENT HAD MULTIPLE BRUISES AND WENT TO ER AFTER LAB DRAW. DATE: (B)(6) 2010, INRATIO: 1.6, LAB: 3.8. TIME BETWEEN METER RESULTS AND LAB DRAW ON (B)(6) 2010 WAS LESS THAN 2 HOURS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other