BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1028092 · Received April 11, 2008

    Report

    Report Number
    2954730-2008-00160
    Event Type
    Malfunction
    Date Received
    April 11, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 1, 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: UNKNOWN, INRATIO: 2.3, LAB: 2.9, MEAN: 2.6, CONFIDENCE LIMITS: 1.7 - 3.8. DATE: 2008, INRATIO: 4.2, LAB: 3.3, MEAN: 3.75, CONFIDENCE LIMITS: 2.2 - 5.3. DATE: A WEEK LATER, INRATIO: 3.4, LAB: 2.5, MEAN: 3.0, CONFIDENCE LIMITS: 1.8 - 4.2. DATE: THE SAME DAY, INRATIO: 3.1, LAB: 2.5, MEAN: 2.8, CONFIDENCE LIMITS: 1.8 - 4.2. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR ALL 4 DATA SETS, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE CONSIDERED NOT DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS NOT REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: 070533. FIRST TEST INR = 3.4; SECOND INR = 3.1. MEAN = 3.25; SD = 0.21; %CV = 6.52. THE %CV IS LESS THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: UNKNOWN, INRATIO: 2.3, LAB: 2.9; DATE: 2008, INRATIO: 4.2, LAB: 3.3 DATE: A WEEK LATER, INRATIO: 3.4, LAB: 2.5; DATE: THE SAME DAY, INRATIO: 3.1, LAB: 2.5. CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 3.4; SECOND TEST INR = 3.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ BOXED STRIPS, 12-PK, MULTILANGUA 070533

    Patients

    Seq Age Sex Outcome Treatment
    1