BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2231031 · Received July 19, 2011

    Report

    Report Number
    2027969-2011-01582
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS ON ANTIBIOTICS. PATIENT MEDICATION MAY INTERFERE WITH COAGULATION TEST AND MAY LEAD TO INACCURATE INR RESULTS OR TESTING ERRORS. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 3.5 INR, REFERENCE: 2.5 INR, MEAN: 3.00, CONFIDENCE LIMITS: 1.8-4.2. 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. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. 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. PATIENT WAS TAKING ANTIBIOTICS AND HAS THYROID DISORDER. PATIENT'S ANTIBIOTIC USE AND MEDICAL CONDITION AS A CAUSE OF THE UNEXPECTED RESULTS CANNOT BE RULED OUT. (B)(4). FROM (B)(6) 2010 TO (B)(6) 2011, THERE HAVE BEEN 13 THERAPEUTIC AND 4 NORMAL DONOR SAMPLE TESTS PERFORMED. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 3.5, LAB: 2.5. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.1-2.6. THE METER RESULT WAS DONE THE SAME DAY AND WITHIN A FEW HOURS OF THE LAB RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 248203

    Patients

    Seq Age Sex Outcome Treatment
    1