BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1267819 · Received December 10, 2008

    Report

    Report Number
    2954730-2008-00712
    Event Type
    Other
    Date Received
    December 10, 2008
    Date of Event
    December 1, 2008
    Report Date
    December 8, 2008
    Manufacturer
    HEMOSENSE INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS WHEN REPEATED THE TEST WITH THE INRATIO METER. THE RESULTS ARE AS FOLLOWS: SEE SCANNED TABLE. AS PER INTERNAL PROCEDURE, IF THE %CV IS LESS THAN 20% THE CRITERION IS MET. THE PRODUCT WILL NOT BE INVESTIGATED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN REPEATED THE TEST WITH INRATIO METER. PT IS WILLING TO SEND BACK THEIR METER AND 6 LOOSE STRIPS. L2 ISSUED REPLACEMENT METER AND 1 BX OF 12 STRIPS. CUSTOMER SATISFIED. NIA, PLS. SEND 1 METER, 1 BX OF 12 STRIPS AND HS-RGA KIT 2, OVERNIGHT FREE OF CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE INC. 0100139 080076A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI