BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2214557 · Received August 3, 2011

    Report

    Report Number
    2027969-2011-01713
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B)(6) 2011, 1ST INR: 1.0, 2ND INR: 1.5, MEAN: 1.25, SD: 0.35, %CV: 28.28. SINCE %CV IS MORE THAN 20%, THE TEST FAILED THE CRITERIA FOR PRECISION. ADDITIONAL INVESTIGATION IS REQUIRED. RECENT TEST CONDUCTED ON LOT #253026 ON 7/13/2011 MET PRECISION CRITERIA. TEST RESULTS ARE AS FOLLOWS: DONOR 72 = 4.3, 4.2, 4.4 INR; DONOR 73 = 2.6, 2.1, 2.5 INR. IN-HOUSE TEST RESULTS HAVE 2.33% AND 11.02%, 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 REPEAT INRATIO TESTING REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAIN TESTING OF THE LOT MET PRECISION CRITERIA. THE PATIENT WAS IDENTIFIED AS WIPING THE FIRST DROP PRIOR TO TESTING. DELAYS IN SAMPLE APPLICATION TO THE TEST MAY IMPACT THE ACCURACY OF RESULTS. SAMPLE SHOULD BE APPLIED TO THE STRIP IMMEDIATELY AND WITHIN 15 SECONDS. PATIENT ALSO HAS A HISTORY OF ANEMIA AND LEUKEMIA. PATIENT'S CONDITIONS AS A CAUSE OF THE UNEXPECTED RESULTS CANNOT BE RULED OUT. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4) NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION 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: 1.0, PROTHROMBIN TIME: 9.6 (INITIAL); (B)(6) 2011, 1.5, 15.4. REPEAT TESTING WAS DONE WITHIN A FEW MINUTES USING A DIFFERENT FINGER/FINGER STICK. PATIENT HAS BEEN ON COUMADIN FOR FOUR WEEKS; LAST DOSE OF COUMADIN WAS TAKEN LAST NIGHT. PHYSICIAN HAS NOT SET A THERAPEUTIC RANGE FOR THE PATIENT. CUSTOMER REPORTS WIPING OFF THE FIRST DROP OF BLOOD BEFORE APPLYING TO STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 253026

    Patients

    Seq Age Sex Outcome Treatment
    1