BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1012832 · Received March 11, 2008

    Report

    Report Number
    2954730-2008-00113
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 11, 2008
    Manufacturer
    HEMOSENSE SJ
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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: 2008; INRATIO: 1.5; LAB: 2.1; MEAN: 1.8; CONFIDENCE LIMITS: 1.3-2.7; DATE: THREE DAYS LATER; INRATIO: 4.7; LAB: 5.69; MEAN: 5.195; CONFIDENCE LIMITS: CANNOT BE DETERMINED; DATE: THE FOLLOWING DAY; INRATIO: 2.5 (PT#1); 1.7 (PT#2); LAB: 3.3, 2.3; MEAN: 2.9; 2.0; CONFIDENCE LIMITS: 1.8-4.2; 1.3-2.7. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE SECOND SET OF DATA, THE MEAN WAS > 5.0 AND THE DIFFERENCE BETWEEN INR'S WAS <2.2. THE VALUES WERE NOT CONSIDERED INACCURATE. FOR THE REST OF THE DATA SETS, BOTH INRATIO AND LAB 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. THEREFORE FURTHER TESTING IS NOT REQUIRED AT THIS TIME. PRODUCTS WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2008; INRATIO: 1.5; LAB: 2.1; DATE: THREE DAYS LATER; INRATIO: 4.7; LAB: 5.69; DATE: THE FOLLOWING DAY; INRATIO: 2.5 (PT#1); 1.7 (PT.2); LAB: 3.3; 2.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ 070384

    Patients

    Seq Age Sex Outcome Treatment
    1