BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2121505 · Received May 6, 2011

    Report

    Report Number
    2027969-2011-01009
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 5.6, 2ND INR: 1.9, 3RD INR: 2.8, MEAN: 3.43, SD: 1.93, %CV: 56.20. 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 PERFORMED ON 04/20/2011 REVEALED THAT RESULT COMPARISONS MET PRECISION CRITERIA. INVESTIGATION RESULTS FOR RETAINED STRIP LOT #247451: DONOR 1, 1ST INR: 2.2, 2ND INR: 2.1, 3RD INR: 2.3, MEAN: 2.20, SD: 0.10, %CV: 4.55. DONOR 2, 1ST INR: 4.2, 2ND INR: 3.7, 3RD INR: 4.2, MEAN: 4.03, SD: 0.29, %CV: 7.16. PERCENT CV FOR BOTH DONORS ARE BELOW 20%, PRECISION CRITERIA HAS BEEN MET. NO FURTHER TESTING IS NEEDED. AS REVIEWED ON 05/06/2011, EIGHTY-FOUR DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #247451, YIELDING A COMPLAINT RATE OF 0.081%. ACTION THRESHOLD (>0.07%) 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). ONE HUNDRED AND EIGHTY-TWO TOTAL DISCREPANT COMPLAINTS HAVE BEEN REPORTED FOR LOT #247450 AND #247451, YIELDING A COMPLAINT RATE OF 0.02%. DUE TO THIS LOW OCCURRENCE RATE BELOW TOTAL COMPLAINT ACTION THRESHOLD OF 0.1%, 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, INRATIO2: 5.6, 1.9, 2.8. PT'S THERAPEUTIC RANGE: 2-3 INR. PT HAS BEEN TESTING SINCE (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 NI