BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INR CARTRIDGE

    MDR report key: 2515993 · Received March 30, 2012

    Report

    Report Number
    2245578-2012-00256
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    December 7, 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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 U.S. FOOD AND DRUG ADMINISTRATION.

    Description of Event or Problem · 1

    ON (B)(4) 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 USING TWO DIFFERENT I-STAT LOTS. METHOD: CA 1500, TIME: 09:00, INR: 1.3 FROM PIC LINE. METHOD: I-STAT, TIME: 09:28, INR: 2.0 FROM PIC LINE, LOT NUMBER R11204. METHOD: I-STAT, TIME: 09:38, INR: 1.9 FROM PIC LINE, LOT NUMBER R11204. METHOD: I-STAT, TIME: 09:47, INR: 1.9 VENOUS DRAW, LOT NUMBER R11271B. METHOD: CA 1500, TIME: 10:00, INR: 1.3 NEW SAMPLE. THE CUSTOMER DID NOT RETURN ANY PRODUCT FOR INVESTIGATION. LOT NUMBER: R11204, MANUFACTURE DATE: 07/2011, EXPIRATION DATE: 01/14/2012. LOT NUMBER: R11271B, MANUFACTURER DATE: 09/2011, EXPIRATION DATE: 03/14/2012. BASED ON THE INFORMATION 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 CARTRIDGE PT/INR CARTRIDGE GJS ABBOTT POINT OF CARE, INC. NA R11204

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR