BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1942310 · Received December 22, 2010

    Report

    Report Number
    2027969-2010-02239
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 22, 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
    KY, 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: 5.1, REFERENCE: 7.9, MEAN: 6.50, CONFIDENCE LIMITS: N/A. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT BOTH INRATIO AND REFERENCE INR VALUES WERE GREATER THAN 5.0. INR RESULTS EXCEEDING 5.0 GENERALLY HAVE REDUCED ACCURACY. PRECISION AND LINEARITY, BOTH IN POINT-OF-CARE AND LABORATORY BASED PT TESTING. CONFIDENCE LIMITS WERE NOT DERIVED FROM CUSTOMER'S RESULTS. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT TEST RESULT COMPARISONS MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION REQUIRED AT THIS TIME. AS REVIEWED ON 12/22/2010, SEVENTEEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #237432 YIELDING A COMPLAINT RATE OF 0.003%. 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. INVESTIGATION RESULTS FROM A PREVIOUS CASE ON STRIP LOT #237432. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. (B)(4) REPLICATES FOR BOTH SAMPLES OF STRIP LOT 237432 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INRATIO: 5.1, LAB: 7.9. 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. 100139 237432

    Patients

    Seq Age Sex Outcome Treatment
    1 NI