BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2121352 · Received May 5, 2011

    Report

    Report Number
    2027969-2011-00999
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 5, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.0; 2ND INR: 1.5; MEAN: 1.25; SD: 0.35; %CV: 28.28. 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 RESULT COMPARISONS MET PRECISION CRITERIA. INVESTIGATION RESULTS FROM A PREVIOUS CASE: DONOR 12, RETURN1: 1.6; IN-HOUSE2: 1.6; IN-HOUSE3: 1.6; MEAN: 1.6; SD: 0.00; %CV: 0.00. DONOR 13: 2.7, 2.8, 2.7, 2.73, 0.06, 2.11. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE TESTED ON STRIP LOT 247451, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE %CV RESULTS WERE 0% AND 2.11%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METERS. NO FURTHER ACTION IS REQUIRED. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE 62935 WHICH BRICK LOT #237418 WAS ASSIGNED AND PACKAGED INTO TWO STRIP LOTS (247450 AND 247451). (B)(4). DUE TO THIS LOW OCCURRENCE RATE BELOW TOTAL COMPLAINT ACTION THRESHOLD OF(B)(4), NO FURTHER ACTION IS REQUIRED. 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) 2011; INRATIO: 1.0, 1.5. 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 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 NI