BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 824142 · Received February 2, 2007

    Report

    Report Number
    2954730-2007-00054
    Event Type
    Malfunction
    Date Received
    February 2, 2007
    Date of Event
    January 10, 2007
    Report Date
    January 30, 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: 01/10/07, INRATIO: 1.5, LAD: 4.5, MEAN 3.0, CONFIDENCE LIMITS: 1.8-4.2. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE INRATIO VALUE WAS OUTSIDE THE CONFIDENCE LIMITS FOR INR TESTING. PRODUCTS WILL BE TESTED. LOT 040690 EXPIRED ON 11/2005. QC ONLY KEEPS RETAINS FOR 2 MONTHS AFTER EXPIRATION. NO RETAINS FOR THIS LOT ARE AVAILABLE. NO FURTHER TESTING CAN BE PERFORMED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 01/10/07, INRATIO: 1.5, LAB: 4.5 . JANUARY 10, 2007; 8:23AM: INRATIO = 1.5, INRATIO = 1.5, RETEST WITH 2ND FS, LAB = 4.5 WITHIN 30MINS. TECHNICAL SPORT UPDATED THIS CASE ON 01/10/2007. PER TEXT "HER TECHNIQUE WAS CHECKED AND CORRECT, BUT ANSWERING TS QUESTIONS ABOUT THE STRIPS, IT WAS FOUND OUT THAT SHE HAS BEEN USING STRIP LOT# 040690C WITH EXPIRATION DATE OF 11/2005."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 040690

    Patients

    Seq Age Sex Outcome Treatment
    1 *