BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2231276 · Received July 25, 2011

    Report

    Report Number
    2027969-2011-01633
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 3.6, REFERENCE: 2.5, MEAN: 3.05, CONFIDENCE LIMITS: 1.8 - 4.2; (B)(6) 2011, 2.6, 2.5, 2.55, 1.6 - 3.4. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2011, 1ST INR: 3.6, 2ND INR: 2.6, MEAN: 3.10, SD: 0.71, %CV: 22.81. SINCE %CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADD'L INVESTIGATION IS REQUIRED. RECENT TEST CONDUCTED ON LOT #243104 ON 7/20/2011 MET PRECISION CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 74 = 2.1, 1.9, 2.0 INR; DONOR 75 = 3.6, 3.7, 3.7 INR. IN-HOUSE TEST RESULTS HAVE 5.00% AND 1.57%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16% CV. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. ANALYSIS OF THE CLIENT'S DATA FROM REPEAT INRATIO TESTING REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAIN STRIP TESTING RESULTS MET PRECISION CRITERIA. UNABLE TO DETERMINE ROOT CAUSE BASED ON THE INFO PROVIDED. (B)(4). THIS REACHES THE ACTION THRESHOLD OF (B)(4). NOTE BRICK LOT NUMBER 246544 HAS STRIP CODE Z45BU. MATERIAL WAS SPLIT INTO TWO DIFFERENT LOTS: LOT # 243104 INTO 12 PACKS (SMALLER LOT), LOT # 251117 INTO 48 PACKS (LARGER LOT). (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD OF (B)(4). CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 3.6, LAB: 2.5. METER AND LAB TESTING WAS DONE AT THE SAME TIME. PT ALSO TESTED WITH A DIFFERENT STRIP LOT NUMBER AND RECEIVED AN INRATIO RESULT OF 2.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100071 243104

    Patients

    Seq Age Sex Outcome Treatment
    1