BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1911466 · Received November 18, 2010

    Report

    Report Number
    2027969-2010-01998
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: 1.5, REFERENCE: 2.3, MEAN: 1.90, CONFIDENCE LIMITS: 1.3-2.7. THE 1.4 AND 2.5 INR RESULTS WERE 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 MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. PER GENERAL DESCRIPTION OF COMPLAINT, PATIENT HAD A LOVENOX SHOT. PER PRODUCT USER GUIDE, INRATIO TESTING SHOULD NOT BE USED FOR PATIENTS ON HEPARIN THERAPY. AS OF 11/18/2010, FORTY-FIVE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #234526 YIELDING A COMPLAINT RATE OF 0.010%. 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. 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) 2010, INRATIO: 1.4, LAB: NG. DATE: (B)(6) 2010, INRATIO: 2.5, LAB: NG. DATE: (B)(6) 2010, INRATIO: 1.5, LAB: 2.3. 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 234526

    Patients

    Seq Age Sex Outcome Treatment
    1 NI