BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2492253 · Received March 13, 2012

    Report

    Report Number
    2027969-2012-00325
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    May 20, 2011
    Report Date
    March 13, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE: (B)(6) 2011. INRATIO: 2.40, HOSPITAL: 1.82, MEAN: 2.11, CONFIDENCE LIMITS: 1.3 - 2.7, PASS/FAIL: PASS. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM 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. NO FURTHER INVESTIGATION IS REQUIRED. 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. NO PRODUCT WAS EXPECTED TO BE RETURNED. IN-HOUSE THERAPEUTIC SAMPLE TEST HISTORY REVEALED CUSTOMER'S OBSERVATION WAS NOT REPLICATED AND TEST RESULTS HAVE BEEN WITHIN THE ALLOWABLE DIFFERENCE (+/- 30%) SET BY WHO AND ISO. AS REVIEWED ON (B)(6) 2012, (B)(4) DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #243103 YIELDING A COMPLAINT RATE OF (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE 9705R WHICH BRICK LOT NUMBER 237416 WAS ASSIGNED AND PACKAGED INTO STRIP LOTS (243013, 246446 AND 246450); THEREFORE (B)(4) TOTAL DISCREPANT COMPLAINTS HAVE BEEN REPORTED FOR LOT NUMBERS 243103, 246446 AND 246450 YIELDING A COMPLAINT RATE OF (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF (B)(4), CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, HOSPITAL INR: 1.82, INRATIO2 INR: 3.40. CUSTOMER IS A PATIENT SELF TESTER. COUMADIN DOSE WAS ADJUSTED. SELEPARINA WAS ADMINISTERED BECAUSE INR WAS BELOW 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC HS0100071 243103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other