BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 922244 · Received March 30, 2007

    Report

    Report Number
    2954730-2007-00143
    Event Type
    Malfunction
    Date Received
    March 30, 2007
    Date of Event
    March 16, 2007
    Report Date
    March 23, 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 060736: IN 2007: FIRST TEST INR=4.8, SECOND TEST INR=1.5, MEAN=3.15; SD=2.33; %CV=74%. THE %CV IS GREATER 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060736: MEAN=2.4; SD=1.13; %CV=47%. THE %CV IS GREATER 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. TECHNICAL SUPPORT UPDATED THIS CASE FIVE DAYS LATER. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060736: FIRST TEST INR=4.4, SECOND TEST INR=4.2, MEAN=4.3; SD=0.14; %CV=3.2%. 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. RESULT OF RETAINED STRIPS TEST (LOT 060736) PERFORMED TWENTY DAYS EARLIER AS FOLLOWS: LOT 060736 PT#1: NORMAL=1.0, NORMAL=1.2, MEAN=1.1, SD=0.14, %CV=12.8%; PT#2: NORMAL=1.1, NORMAL=1.1, MEAN=1.1, SD=0, %CV= 0%. BASED ON THE ABOVE TEST RESULTS, PER INTERNAL PROCEDURE, RETAINED STRIPS LOT 060736 MEETS THE CRITERIA FOR STRIP PRECISION.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: IN 2007: FIRST TEST INR=4.8, SECOND TEST INR=1.5, SAME DAY: FIRST TEST INR=3.2, SECOND TEST INR=1.6. TECHNICAL SUPPORT UPDATED THIS CASE FIVE DAYS LATER. FIRST TEST INR=4.4, SECOND TEST INR=4.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060736

    Patients

    Seq Age Sex Outcome Treatment
    1 *