BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1978434 · Received January 28, 2011

    Report

    Report Number
    2027969-2011-00204
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER ISSUE, PT JUST STARTED TAKING ANTIBIOTICS. PER PRODUCT USER GUIDE, "CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (E.G., ANTIBIOTICS, PAIN RELIEVERS) CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS. STARTING, STOPPING OR CHANGING THE DOSE CAN AFFECT THE INR VALUE." INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2011, 1ST INR: 1.5, 2ND INR: 2.0, MEAN: 1.75, SD: 0.35, %CV: 20.20. SINCE % CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADD'L INVESTIGATION IS REQUIRED. PREVIOUS INVESTIGATION OF STRIP LOT 233708 FROM (B)(6) 2011 MET PRECISION CRITERIA. DATE: (B)(6) 2011. DONOR 1: 1ST INR: 3.4, 2ND INR: 3.3, 3RD INR: 3.3, MEAN: 3.3, SD: 0.06, %CV: 1.73. DONOR 2: 1ST INR: 2.7, 2ND INR: 2.7, 3RD INR: 2.6, MEAN: 2.67, SD: 0.06, %CV: 2.17. PT TAKING ANTIBIOTICS MAY AFFECT INR TESTING. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAIN STRIP TEST RESULT COMPARISON MET PRECISION CRITERIA. AS REVIEWED ON (B)(6) 2011, (B)(4) DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT #233708 YIELDING A COMPLAINT RATE OF 0.083%. ACTION THRESHOLD HAS REACHED. SINCE STRIP LOT 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 THE RESULTS FROM IN VIVO TESTS. 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 RESULT WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 1.5, RETEST INRATIO: 2.0. PT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5. PT WAS HOSPITALIZED ON (B)(6) 2010 WITH BLACK STOOLS/GASTROINTESTINAL BLEEDING. PT STARTED TAKING ANTIBIOTICS 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 233708

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O