BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 900514 · Received August 20, 2007

    Report

    Report Number
    2954730-2007-00382
    Event Type
    Malfunction
    Date Received
    August 20, 2007
    Date of Event
    July 31, 2007
    Report Date
    August 16, 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 070163: DATE: IN 2007 - 1ST STICK, FIRST TEST INR = 1.2, SECOND TEST INR = 2.1, MEAN = 1.65; SD = 0.64; %CV = 38.6%. SECOND STICK, FIRST TEST INR = 1.5, SECOND TEST INR = 1.1, MEAN = 1.30; SD = 0.28; %CV = 21.8%. THE %CV IS GREATER THAN 20% FOR BOTH DATA SETS. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION FAILS THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: 1ST STICK, FIRST TEST INR = 1.2, SECOND TEST INR = 2.1. SECOND STICK, FIRST TEST INR = 1.5, SECOND TEST INR = 1.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070163

    Patients

    Seq Age Sex Outcome Treatment
    1 YR