BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2121499 · Received May 6, 2011

    Report

    Report Number
    2027969-2011-01005
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(4) 2011, INVALID STRIP LOT 234528 PROVIDED BY CUSTOMER. UNABLE TO PERFORM IN-HOUSE INVESTIGATION. NO FURTHER INVESTIGATION WILL BE PURSUED. PT HAD LAST LOVENOX INJECTION ON (B)(6) 2011, BUT HAS MORE THAN 48 HRS LAPSE WHEN IT PERFORMED COAGULATION TEST AND HAS NO DIRECT EFFECT ON INR RESULT. HOWEVER, PT IS TAKING MORPHINE AND VICODIN AT THE TIME OF COAGULATION TEST AND MAY CONTRIBUTE TO UNEXPECTED OR INACCURATE INR RESULT. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. INRATIO AND REFERENCE VALUES OF TEST 2 AND 4 RESPECTIVELY FALL OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTINGS AS PART OF THE COMPLAINT INVESTIGATION. INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2011, 1ST INR: 1.0, 2ND INR: 1.5, MEAN: 1.25, SD: 0.35, %CV: 28.28. DATE: (B)(6) 2011, 1ST INR: 1.0, 2ND INR: 1.3, MEAN: 1.15, SD: 0.21, %CV: 18.45. SINCE TEST 1 HAS MORE THAN 20% CV, INRATIO METER RESULTS FAILED THE CRITERIA FOR PRECISION. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT 2 OUT OF 6 TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. PT'S CONDITION COULD NOT BE RULED OUT AS A CAUSE. NO PRODUCT WAS EXPECTED TO BE RETURNED. PRODUCT OUTER LOT# PROVIDED BY CUSTOMER DOES NOT CORRESPOND TO A VALID LOT NUMBER. 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

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 1.3, LAB: 1.5. DATE: (B)(6) 2011, INRATIO: 1.0, RETEST INRATIO: 1.5, LAB: 1.65. DATE: (B)(6) 2011, INRATIO: 1.0, RETEST INRATIO: 1.3 (BOTH DONE NEAR 7AM). DATE: (B)(6) 2011, INRATIO: 1.4, LAB: 2.1. THE 2.1 LAB RESULT ON (B)(6) 2011 DONE AT 9:30 AM. THE 1.4 METER RESULT ON (B)(6) 2011 DONE AT 11:00 AM. PT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0. PT' SELF TESTER IS CURRENTLY IN THE HOSPITAL DUE TO BACK SURGERY. SHE STOPPED TAKING COUMADIN ON (B)(6) 2011, BEGAN LOVENOX INJECTIONS ON (B)(6) 2011, AND WAS ADMITTED TO THE HOSPITAL FOR SURGERY ON (B)(6) 2011. PT STARTED COUMADIN AGAIN BUT IS UNSURE WHEN EXACTLY DUE TO BEING ON MORPHINE AND VICODIN IN THE HOSPITAL. SHE STOPPED LOVENOX ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234528

    Patients

    Seq Age Sex Outcome Treatment
    1