BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2231281 · Received July 25, 2011

    Report

    Report Number
    2027969-2011-01636
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS MILKING THE FINGER. MILKING THE FINGER MAY CAUSE CONTAMINATION WITH INTERSTITIAL FLUIDS AND MAY LEAD TO INACCURATE INR RESULT OR TESTING ERROR. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 3.6, REFERENCE: 2.5, MEAN: 3.05, CONFIDENCE LIMITS: 1.8 - 4.2. 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. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT WAS EXPECTED TO BE RETURNED. THE PT WAS SAID TO HAVE MILKED THE FINGER TO OBTAIN SUFFICIENT SAMPLE. THIS IMPROPER SAMPLE COLLECTION TECHNIQUE COULD NOT BE RULED OUT AS A CAUSE FOR THE UNEXPECTED RESULT. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. FROM 8/19/2010 TO 7/25/2011, THERE HAVE BEEN 16 THERAPEUTIC AND 2 NORMAL DONORS TESTED. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE REQUIREMENTS WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 3.6, DR'S POC: 2.5. TESTING WAS DONE 1 HOUR APART. PT SELF TESTER IS MILKING THE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1