BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1960858 · Received December 17, 2010

    Report

    Report Number
    2027969-2010-02204
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 17, 2010
    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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.3, 2ND INR: 1.9, MEAN: 1.60, SD: 0.42, %CV: 26.52. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED INACCURATE WITHIN 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 TEST RESULT COMPARISONS MET PRECISION CRITERIA. INVESTIGATION RESULTS FROM A PREVIOUS CASE: DONOR: 1, RETURN1: 3.4, IN-HOUSE2: 3.7, IN-HOUSE3: 3.4, MEAN: 3.50, SD: 0.17, %CV: 4.95. DONOR: 2, 2.1, 2.3, 2.2, 2.20, 0.10, 4.55. FOR EACH PAIR OF REPLICATES, FOR EACH SAMPLE OF STRIP LOT 237432, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS WERE 4.95% AND 4.55%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METERS. NO FURTHER ACTION IS REQUIRED. (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.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INR: 1.3, 1.9. PT'S THERAPEUTIC RANGE: 2-3 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 237432

    Patients

    Seq Age Sex Outcome Treatment
    1 NI