BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2052499 · Received March 15, 2011

    Report

    Report Number
    2027969-2011-00496
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (PRECISION): COMPARISON OF INRATIO TEST RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.3, INRATIO: 2.1, MEAN: 1.7, SD: 0.566, %CV: 33.28, RESULT: FAIL. SINCE %CV IS GREATER THAN 20%, INRATIO METER RESULTS FAIL THE CRITERIA FOR PRECISION. THE RESULTS ARE CONSIDERED DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. PER COMPLAINT, USER REPORTED PATIENT ON ANTIBIOTIC MEDICATION AT THE TIME OF TESTING. PER PRODUCT INSERT, "CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (E.G., ANTIBIOTICS, PAIN RELIEVERS) CAN AFFECT THE ACTION OF ORAL ANTI-COAGULANTS." INTRODUCING A BUBBLE WHILE USING CAP TUBE COULD CAUSE INACCURATE INR TEST RESULTS. NO PRODUCT ASSOCIATED WITH THE COMPLAINT IS EXPECTED FOR RETURN. RETAIN TESTING OF REPORTED LOT 243934 IS REQUIRED. IN-HOUSE TESTING HAS BEEN PERFORMED 03-MARCH-2011 WITH PASSING RESULTS AS FOLLOWS: DATE AND DONOR: 03/03/2011 #1, INRATIO: 3.5, INRATIO: 3.5, INRATIO: 3.7, MEAN: 3.57, SD: 0.115, %CV: 3.24, RESULT: PASS. DATE AND DONOR: 03/03/2011 #2, INRATIO: 2.0, INRATIO: 2.1, INRATIO: 2.3, MEAN: 2.13, SD: 0.153, %CV: 7.16, RESULT: PASS. BOTH DONOR RESULT %CVS ARE BELOW 20%; PRECISION CRITERIA HAVE BEEN MET. NO FURTHER TESTING IS NEEDED. (B)(4). ACTION THRESHOLD WAS REACHED. SINCE STRIP LOT WAS RELEASED, IN-HOUSE THERAPEUTIC SAMPLE TESTS WERE PERFORMED FOR RETAIN AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN TEST. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO RESULTS FROM IN VIVO TESTS. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, 1ST INR: 1.3, 2 INR: 2.1, THERAPEUTIC RANGE: (2-3). PATIENT USES FIRST LARGE HANGING DROP AND TRANSFERS WITH MICROSAFE TUBE; THERE WERE BUBBLES THAT WERE MANIPULATED OUT OF THE TUBE SO IT MAY HAVE BEEN LONGER THAN 15 SECONDS TO TRANSFER THE SAMPLE. PATIENT IS ON ANTIBIOTIC EYE DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI