BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1082070 · Received July 23, 2008

    Report

    Report Number
    2954730-2008-00472
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 22, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 070308: FIRST TEST INR = 3.5 (WEDNESDAY); SECOND TEST INR = 2.7 (FRIDAY); MEAN = 3.95; SD = 0.63; %CV = 16%. 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. THE COMPARISON WAS CONSIDERED INVALID. PER TEXT, "THE CUSTOMER INTERRUPTED AND SAID "THANKS FOR NOTHING" AND HUNG UP." CALLER UNWILLING TO PROVIDE MORE INFO. INSUFFICIENT INFO AVAILABLE. NO FURTHER TESTING CAN BE PERFORMED.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: FIRST TEST INR = 3.5 (WEDNESDAY); SECOND TEST INR = 2.7 (FRIDAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100007 NP

    Patients

    Seq Age Sex Outcome Treatment
    1 NI