BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 727473 · Received June 9, 2006

    Report

    Report Number
    2954730-2006-00347
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Date of Event
    May 31, 2006
    Report Date
    June 7, 2006
    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 050435: 05/31/06 FIRST TEST INR = 7.1 SECOND TEST INR = 5.1, MEAN = 6.1; SD = 1.4; %CV = 23%. THE %CV IS GREATER 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILED THE CRITERIA FOR PREVISION. RETAIN STRIPS WILL BE INVESTIGATED. RESULTS OF TESTS PERFORMED ON 4/12/2006: PT #1 - NORMAL, 050435 RETAINS = 1.0, PT #2 NORMAL, 050435 RETAINS = 0.9, PT #1 - NORMAL, 050435 RETAINS = 0.9, PT #2 NORMAL, 050435 RETAINS = 0.9, PT #1 MEAN, 050435 RETAINS = 0.95, PT #2 MEAN 0.9; PT #1: SD, 050435 = 0.07, PT #2: SD, 050435 RETAINS = 0.00, PT #1: %CV 050435 RETAIN = 7.4%, PT #2: %CV, 050435 RETAIN = 0.0%. PER PR 130, LOT 050435 PASSES THE CRITERIA FOR PRECISION. CASE UPDATED BY TS ON 06/02/06. DATE: 06/02/06, INRATIO = 4.6, LAB = 5.3, MEAN = 4.95, CONFIDENCE LIMITS = 2.8-7.2 PER INTERNAL PROCEDURE, TR 0150, THE CALCULATED 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 IMPRECISION RESULTS WITH INRATIO. RESULTS AS FOLLOWS: 05/31/06 FIRST TEST INR = 7.1 SECOND TEST INR = 5.1. CASE UPDATED BY TECHNICAL SUPPORT ON 06/02/06. CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE 06/02/06 INRATIO=4.6, LAB=5.3

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050435

    Patients

    Seq Age Sex Outcome Treatment
    1 *