BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1960827 · Received December 17, 2010

    Report

    Report Number
    2027969-2010-02211
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    October 25, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS PERFORMED ON INR RESULTS PROVIDED BY CUSTOMER. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2010; INRATIO: 1.7 INR; REFERENCE: 2.78 INR; MEAN: 2.24; CONFIDENCE LIMITS: 1.4-3.1. DATE: (B)(6) 2010; INRATIO: 3.5 INR; REFERENCE: 2.78 INR; MEAN: 3.14; CONFIDENCE LIMITS: 1.9-4.6. A 2.5 INR IS EXCLUDED FROM COMPARISON TEST DUE TO NO CORRESPONDING INR RESULT AND IS FROM ROCHE COAGUCHECK SELF-TEST. THE MEAN OF THE INRATIO METER 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 IS REQUIRED. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4), 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: NG; INRATIO: 1.7, 3.5; LAB: 2.78. TESTING ON ROCHE COAGUCHECK XS = 2.5. DISCREPANCIES WERE NOTED DURING TRAINING AT A TRAINING CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008EU 232168

    Patients

    Seq Age Sex Outcome Treatment
    1