BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 922141 · Received March 30, 2007

    Report

    Report Number
    2954730-2007-00149
    Event Type
    Malfunction
    Date Received
    March 30, 2007
    Date of Event
    March 20, 2007
    Report Date
    March 28, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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= LAST WEEK: INRATIO=3.8, LAB=1.6, MEAN=2.7, CONFIDENCE LIMITS= 1.7-3.8; IN 2007: PT#1 INRATIO=2.7, LAB=1.8, MEAN=2.25, CONFIDENCE LIMITS=1.4-3.1; PT#2 INRATIO=2.9, LAB=2.1, MEAN=2.5, CONFIDENCE LIMITS=1.6-3.4; PT#3 INRATIO=2.7, LAB=2.9, MEAN=2.8, CONFIDENCE LIMITS=1.8-4.2; PT#4 INRATIO=1.6, LAB=2.4, MEAN=2.0, CONFIDENCE LIMITS=1.3-2.7; PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATA, THE LAB VALUE WAS OUTSIDE THE CONFIDENCE LIMITS FOR INR TESTING. PRODUCTS WILL BE TESTED. THE STRIPS LOT 050606 EXPIRED ON 09/30/2006. CUSTOMER USED EXPIRED STRIPS. PRODUCTS MISUSED. RETAINED STRIPS ARE UNAVAILABLE FOR TESTING. QC ONLY KEEP RETAINED STRIPS FOR TWO MONTHS AFTER THE EXPIRATION DATE. NO RETAIN STRIPS AVAILABLE FOR TESTING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE= LAST WEEK: INRATIO=3.8, LAB=1.6; IN 2007: PT#1 INRATIO=2.7, LAB= 1.8; PT#2 INRATIO=2.9, LAB=2.1; PT#3 INRATIO=2.7, LAB=2.9; PT#4 INRATIO=1.6, LAB=2.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 050606

    Patients

    Seq Age Sex Outcome Treatment
    1 *