BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 2161171 · Received June 30, 2011

    Report

    Report Number
    2027969-2011-01444
    Event Type
    Other
    Date Received
    June 30, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WIPES THE FIRST DROP AND USES THE SAME FINGER TO RETEST IF THERE IS NOT ENOUGH SAMPLE. THIS MAY AFFECT COAGULATION TEST AND LEAD TO UNEXPECTED INR OR ERRORS IN TESTING. ONLY THE FIRST DROP SHOULD BE USED AND A FRESH FINGER SHOULD BE USED FOR EACH REPEAT TEST. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011; INRATIO: 1.3; REFERENCE: 2.6; MEAN: 1.95; CONFIDENCE LIMITS: 1.3 - 2.7. 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. PRE-ANALYTICAL ERRORS DURING SAMPLE COLLECTION MAY CONTRIBUTE TO INACCURATE INR RESULT OR TESTING ERROR. THESE ERRORS WERE IDENTIFIED IN THE COMPLAINT AND COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. (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. 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: UNK; INRATIO: 1.3; LAB: 2.6. LAB RESULT DONE 1-2 HOURS LATER. DATE OF EVENT REPORTED ON (B)(6) 2011 AS "LAST WEEK SOMETIME". PT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 251117

    Patients

    Seq Age Sex Outcome Treatment
    1 Other