BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INRCARTRIDGE

    MDR report key: 4170514 · Received October 14, 2014

    Report

    Report Number
    2245578-2014-00074
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    GJS
    PMA / PMN Number
    K020355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 12/10/2014. RETAIN AND RETURNED CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    N/A

    Description of Event or Problem · 1

    ON (B)(4) 2014, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED UNEXPECTED RESULTS ON I-STAT PT/INR ON A (B)(6) YEAR OLD FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. TEST DATE TIME RESULT SAMPLE(B)(6) 2014 10:00 AM 6.1 A(B)(6) 2014 10:15 AM 3.1 B(B)(6) 2014 10:24 AM 3.2 CBASED 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
    651106 I-STAT PT/INRCARTRIDGE PT/INR CARTRIDGE GJS ABBOTT POINT OF CARE NA T14170D

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR