BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1919659 · Received December 2, 2010

    Report

    Report Number
    2027969-2010-02100
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 2, 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
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.4, 2ND INR: 2.3, MEAN: 1.85, SD: 0.64, %CV: 34.40; 1.7, 2.6, 2.15, 0.64, 29.60. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT BOTH REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT PRECISION CRITERIA WAS MET. ROOT CAUSE OF COMPLAINT COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. INVESTIGATION RESULTS FROM A PREVIOUS CASE: DONOR 1: RETURN1: 3.2, IN-HOUSE2: 3.4, IN-HOUSE3: 3.2, MEAN: 3.27, SD: 0.12, %CV: 3.53; DONOR 2: 3.6, 3.4, 3.5, 3.50, 0.10, 2.86. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE OF STRIP LOT 233708, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS WERE 3.53% AND 2.86%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULTS WERE ESTABLISHED ON INRATIO METERS. NO FURTHER INVESTIGATION WILL BE PURSUED. AS REVIEWED ON 12/01/2010, EIGHTY-NINE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #233708 YIELDING A COMPLAINT RATE OF 0.066%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), 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. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    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 NI