BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1985088 · Received February 3, 2011

    Report

    Report Number
    2027969-2011-00250
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.2, 2ND INR: 4.2, MEAN: 2.70, SD: 2.12, %CV: 78.57. ACCURACY TEST WAS NOT PERFORMED SINCE REPORTED REFERENCE INR WAS TAKEN FOUR TO FIVE HOURS AFTER INRATIO TESTS. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR A COMPARISON TO BE VALID. THE 3.1 INR WAS EXCLUDED FROM PRECISION TEST SINCE TIME BETWEEN TESTS ALSO EXCEEDED THREE HOURS. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT ACCURACY AND PRECISION CRITERIA WERE MET. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4), NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FROM A PREVIOUS CASE ON STRIP LOT #243934. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND SYSMEX INRS WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT #243934 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE OF STRIP LOT #243934, (B)(4). BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. PER ISSUE, PATIENT WAS TAKING SEVERAL MEDICATIONS. PER PRODUCT USER GUIDE, CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS CAN AFFECT THE ACTIONS OF ORAL ANTICOAGULANTS. STARTING, STOPPING OR CHANGING THE DOSE CAN AFFECT THE INR VALUE. IN ADDITION, PATIENT WAS ADDING MORE BLOOD AND WIPING IT OFF WHERE IT MISSED THE TARGET ON THE METER. PER PRODUCT USER GUIDE, ONLY ONE DROP OF BLOOD SHOULD BE USED IN TESTING. ADDING MULTIPLE DROPS MAY AFFECT COAGULATION TEST AND LEAD TO UNEXPECTED INR RESULTS OR ERRORS IN TESTING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.2, LAB: 3.2. INRATIO: 4.2, LAB: 3.2. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.2. INRATIO: 4.2. DATE: (B)(6) 2011, INRATIO: 3.1. PATIENT THERAPEUTIC RANGE: 2.5-3.5 INR.

    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