BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1406822 · Received June 23, 2009

    Report

    Report Number
    2027969-2009-00468
    Event Type
    Injury
    Date Received
    June 23, 2009
    Date of Event
    May 27, 2009
    Report Date
    June 22, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NI

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH INRATIO VERSUS LAB. CALLER TESTED PATIENT AND GOT A READING OF INR>7.5 RETESTED AND HAD INR=3.5. SENT FOR LAB TEST AND INR=14.5. 1.5 HOURS IN BETWEEN INRATIO METER TESTS. PATIENT HAD SIGNS OF BLEEDING; PATIENT HAD GOT SCRATCHED AND WOULD NOT STOP BLEEDING. DOCTOR GAVE PATIENT VITAMIN K TO LOWER INR. CALLER STATED THAT THEY HAD TESTED APPROXIMATELY 40 OTHER PATIENTS THAT DAY, BUT NO OTHER QUESTIONABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 010004 080731A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI