BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INR CARTRIDGES

    MDR report key: 2516030 · Received March 26, 2012

    Report

    Report Number
    2245578-2012-00190
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    December 2, 2011
    Report Date
    March 14, 2012
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    GJS
    PMA / PMN Number
    K020355
    Removal / Correction Number
    APOC2012-003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS COMPLETED ON 03/14/2012 AND A DEFICIENCY WAS IDENTIFIED. (B)(4). DETAILS WERE PROVIDED WITH THE ACTION THAT WAS CONDUCTED IN COOPERATION WITH THE UNITED STATES FOOD AND DRUG ADMINISTRATION.

    Description of Event or Problem · 1

    ON (B)(4) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR NOT CORRELATING WITH THE LAB INSTRUMENT USING TWO DIFFERENT LOTS. LOT#: R11288, MANUFACTURE DATE: 10/01/201, EXPIRATION DATE: 03/28/2012. LOT# R11321B, MANUFACTURE DATE: 11/01/2011, EXPIRATION DATE: 05/14/2012. BASED ON THE INFO AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT PT/INR CARTRIDGES PT/INR CARTRIDGES GJS ABBOTT POINT OF CARE INC. NA R11288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA