BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1012833 · Received March 11, 2008

    Report

    Report Number
    2954730-2008-00111
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 13, 2008
    Report Date
    March 10, 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: 3.8; LAB: 2.3; MEAN: 3.1; CONFIDENCE LIMITS: 1.9-4.6; DATE: SAME DAY; INRATIO: 1.7; LAB: 2.3; MEAN: 2.0; CONFIDENCE LIMITS: 1.3-2.7; DATE: SAME DAY; INRATIO: 1.5; LAB: 2.3; MEAN: 1.9; CONFIDENCE LIMITS: 1.3-2.7. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR ALL 3 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. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: 070202. FIRST TEST INR = 3.8; SECOND TEST INR = 1.7; THIRD TEST INR= 1.5. MEAN = 2.3; SD = 1.3; %CV = 54.6. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILS THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME. ADD'L MODEL# 12-PK, MULTILANGUA

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 2008; INRATIO: 3.8; LAB: 2.3; DATE: SAME DAY; INRATIO: 1.7; LAB: 2.3; DATE: SAME DAY; INRATIO: 1.5; LAB: 2.3. CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 3.8; SECOND TEST INR = 1.7; THIRD TEST INR = 1.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ BOXED STRIPS 070202

    Patients

    Seq Age Sex Outcome Treatment
    1