BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2140792 · Received June 15, 2011

    Report

    Report Number
    2027969-2011-01346
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 15, 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
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO2 TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO2: 5.3, REFERENCE: 3.5, MEAN: 4.40, CONFIDENCE LIMITS: 2.5-6.5. INRATIO2: 5.3, REFERENCE: 3.9, MEAN: 4.60, CONFIDENCE LIMITS: 2.5-6.5. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT BOTH INRATIO2 AND REFERENCE TEST RESULT COMPARISONS MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. AS REVIEWED ON (B)(6) 2011, ONE HUNDRED AND SEVENTY-ONE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #243934, YIELDING A COMPLAINT RATE OF 0.128%. ACTION THRESHOLD MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) WAS REACHED. FROM (B)(6) 2010 TO (B)(6) 2011, SIXTEEN THERAPEUTIC AND THREE NORMAL DONOR SAMPLE TESTS HAVE BEEN PERFORMED. TEST RECORDS INDICATED THAT ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE DOCTOR'S METER AND THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 5.3, DOCTOR'S METER: 3.5, LAB: 3.9. NURSE PERFORMED TESTS AT THE DOCTOR'S OFFICE. PATIENT HAS BEEN USING THE METER SINCE 11/22/2010. PATIENT'S THERAPEUTIC RANGE: 2.5-3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI