BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2012872 · Received March 1, 2011

    Report

    Report Number
    2027969-2011-00419
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 2.1, REFERENCE: 2.0, MEAN: 2.05, CONFIDENCE LIMITS: 1.3-2.7. A 1.5 INR WAS EXCLUDED FROM COMPARISON TEST SINCE NO CORRESPONDING REFERENCE OR REPEATED INRATIO VALUE WAS PROVIDED. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID 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 02/15/2011, FOURTEEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #243103, YIELDING A COMPLAINT RATE OF 0.016%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), 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

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.5, LAB: NG. DATE: (B)(6) 2011, INRATIO: 2.1, LAB: 2.0. DOCTOR RAISED PATIENT'S COUMADIN DOSE ON NIGHT OF (B)(6) 2011, DUE TO INRATIO READING. PATIENT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243103

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other