BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1935164 · Received December 6, 2010

    Report

    Report Number
    2027969-2010-02117
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 4, 2010
    Report Date
    December 6, 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
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH . MEAN: 6.35. CONFIDENCE LIMITS: NA. >7.5. 3.0. 5.25. NA. ANALYSIS OF CUSTOMER'S DATE REVEALED THAT BOTH INRATIO AND REFERENCE TEST RESULT COMPARISONS DID NOT MEET ACCURACY CRITERIA. INR RESULTS EXCEEDING 5.0 GENERALLY HAVE REDUCED TRUENESS, PRECISION AND LINEARITY, BOTH IN POINT-OF-CARE AND LAB BASED PT TESTING. NO CONFIDENCE LIMITS COULD BE ESTABLISHED FOR BOTH TESTS. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING FROM A PREVIOUS CASE REVEALED THAT ACCURACY CRITERIA WAS MET. NO FURTHER INVESTIGATION REQUIRED. PER GENERAL DESCRIPTION OF COMPLAINT, PT IS CURRENTLY ON LOVENOX. PER PRODUCT USER GUIDE, LOVENOX USERS ARE ADVISED NOT TO USE INRATIO METER SINCE IT COULD AFFECT COAGULATION TESTING AND LEAD TO INACCURATE INR RESULTS. AS REVIEWED ON 12/03/2010, FIFTY DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #232886 YIELDING A COMPLAINT RATE OF 0.027%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.7%) 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 #232886. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT 232886 ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0). NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND 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: >7.5; LAB: 5.2. DATE: (B)(6) 2010, INRATIO: >7.5; LAB: 3.0. PT'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 232886

    Patients

    Seq Age Sex Outcome Treatment
    1 NI