BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INR CARTRIDGE

    MDR report key: 1760080 · Received June 25, 2010

    Report

    Report Number
    2245578-2010-00036
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Date of Event
    April 19, 2010
    Report Date
    June 25, 2010
    Manufacturer
    ABBOTT POINT OF CARE, CANADA LTD.
    Product Code
    JPA
    Removal / Correction Number
    APOC30APR2010/2245578-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE PROVIDED BACKGROUND INFO ON THE I-STAT PT/INR CARTRIDGE LOT NUMBER T10009 IN COMPARISON TO THE STAGO. THE RESULTS WERE CONSISTENT WITH THE DIFFERENCES IN INSTRUMENTS. THIS LOT WAS ASSOCIATED WITH A PRODUCT ACTION. THERE WAS NO REPORT OF ANY INJURY ASSOCIATED WITH THE INFO PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT PT/INR CARTRIDGE PT/INR CARTRIDGE JPA ABBOTT POINT OF CARE, CANADA LTD. T10009

    Patients

    Seq Age Sex Outcome Treatment
    1