BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2527204 · Received April 6, 2012

    Report

    Report Number
    2027969-2012-00481
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    March 9, 2012
    Report Date
    April 6, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: DATE: (B)(6) 2012, INRATIO METER = 3.1, 3.8, 4.4 AND 4.6 INR. REFERENCE = 5.1 INR, MEAN = 4.20, CONFIDENCE LIMITS = 2.4-6.1. PRECISION TEST WAS PERFORMED ON INRATIO DATA (MEAN = 3.98, SD = 0.68, PERCENT CV = 16.99). SINCE PERCENT CV IS BELOW 20 PERCENT, TEST MET CRITERIA. THE MEAN OF THE INRATIO MEAN 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. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: PATIENT'S INRATIO: 3.1, 3.8, HOSPITAL'S INRATIO: 4.4, 4.6, (VENOUS) COASYS: 5.1. PATIENT HAS BEEN TAKING WARFARIN SINCE 2000; AVERAGE DOSING OF 0.61 FENPROCOUMON. LAST DOSE OF WARFARIN WAS TAKEN THE EVENING BEFORE MEASUREMENT. PATIENT WAS RECENTLY ON ANTIBIOTICS: KLACID FROM (B)(6) TO (B)(6) 2012. RECENT DOSE CHANGES: PREDNISONE FROM (B)(6) TO (B)(6) 2012, (B)(6) 2012 SALBUTAMOL, (B)(6) 2012 PNEUMONIAE. PATIENT HAD A FEVER FROM (B)(6) 2012 UNTIL (B)(6) 2012; 39 DEGREE C. LAST HCT: 0.44 IN (B)(6) 2010. NO RECENT HOSPITALIZATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS0100139 261590

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR