BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INR CARTRIDGE

    MDR report key: 2533147 · Received April 3, 2012

    Report

    Report Number
    2245578-2012-00278
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    October 17, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING PT/INR CARTRIDGES THAT YIELDED A DISCREPANT PT/INR RESULTS WHEN COMPARED TO THE LAB METHOD. CUSTOMER USED SEVERAL LOTS IN 2011. FOR 2011, THE CUSTOMER NOTED THAT 122 INR'S WERE ABOVE 4.0 OUT OF 3233 OR 3.8%. LOT#: R11243B; MFR DATE: 08/2011; EXP DATE: 02/14/2012. LOT#: R11253; MFR DATE: 09/2011; EXP DATE: 02/28/2012. LOT#: R11270; MFR DATE: 09/2011; EXP DATE: 03/14/2012. LOT#: R11272A; MFR DATE: 09/2011; EXP DATE: 03/14/2012. LOT#: R11294B; MFR DATE: 10/2011; EXP DATE: 04/14/2012. BASED ON THE INFO AVAILABLE AT THIS 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 CARTRIDGE PT/INR CARTRIDGE GJS ABBOTT POINT OF CARE INC. NA R11203B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA