BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 824226 · Received February 2, 2007

    Report

    Report Number
    2954730-2007-00051
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    January 23, 2007
    Report Date
    January 29, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060656: 01/10/06 FIRST TEST INR = 4.8, SECOND TEST INR = 6.2, THIRD TEST INR=5.4. MEAN = 5.4; SD = 0.7; %CV = 13%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 01/11/07, INRATIO: 4.7, LAB: (COAGUCHEK) 3.8, MEAN: 4.25, CONFIDENCE LIMITS: 2.4-6.1. DATE: 01/22/07, INRATIO: 6.2, LAB: 3.87, MEAN: 5.035, CONFIDENCE LIMITS: CANNOT BE DETERMINED. INRATIO:6.2, LAB: (DR'S OFFICE) 4.3, MEAN: 5.25, CONFIDENCE LIMITS: CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE SECOND AND THIRD SETS OF DATA, THE CONFIDENCE LIMITS CANNOT BE DETERMINED. PRODUCTS WILL BE TESTED. TS UPDATED THIS CASE ON 01/26/2007. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 01/26/07, INRATIO: PT 1: 4.9(OLD LOT), LAB: 4.06, MEAN: 4.48, CONFIDENCE LIMITS: 2.5-6.5, INRATIO: 4.1 (NEW LOT), LAB: 4.06, MEAN: 4.08, CONFIDENCE LIMITS: 2.4-6.1, INRATIO: PT 2: 3.8(OLD LOT), LAB: 3.2, MEAN: 3.5, CONFIDENCE LIMITS: 2.0-5.0, INRATIO:3.5(NEW LOT), LAB: 3.2, MEAN: 3.35, CONFIDENCE LIMITS: 2.0-5.0. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. 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.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 01/11/07, INRATIO: 4.7; LAB: (COAGUCHEK) 3.8. DATE: 01/22/07, INRATIO:6.2, LAB: 3.87; INRATIO: 6.2, LAB: (DR'S OFFICE) 4.3. CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: 01/10/06 FIRST TEST INR = 4.8, SECOND TEST INR = 6.2, THIRD TEST INR=5.4. TECHINCAL SUPPORT UPDATED THIS CASE ON 01/26/07. DATE: 01/26/07, PT I; INRATIO: 4.9 (OLD LOT), LAB: 4.06. INRATIO: 4.1 (NEW LOT), LAB: 4.06. FIRST INR = 4.9 (OLD LOT), SECOND TEST INR = 4.1 (NEW LOT).

    Description of Event or Problem · 2

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 01/11/07, INRATIO: 4.7; LAB: (COAGUCHEK) 3.8. DATE: 01/22/07, INRATIO:6.2, LAB: 3.87; INRATIO: 6.2, LAB: (DR'S OFFICE) 4.3. CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: 01/10/06 FIRST TEST INR = 4.8, SECOND TEST INR = 6.2, THIRD TEST INR=5.4. TECHINCAL SUPPORT UPDATED THIS CASE ON 01/26/07. DATE: 01/26/07 PT2 INRATIO 3.8 (OLD LOT), LAB: 3.2. FIRST INR = 4.9 (OLD LOT), SECOND TEST INR = 4.1 (NEW LOT). FIRST TEST INR = 3.8 (OLD LOT), SECOND TEST INR = 3.5(NEW LOT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060656

    Patients

    Seq Age Sex Outcome Treatment
    1
    2