BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INRCARTRIDGE

    MDR report key: 3446860 · Received November 4, 2013

    Report

    Report Number
    2245578-2013-00125
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Date of Event
    September 18, 2013
    Report Date
    September 27, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    GJS
    PMA / PMN Number
    K020355
    Removal / Correction Number
    APOC2013-004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS COMPLETED ON (B)(4) 2013 AND A DEFICIENCY WAS IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTS UNEXPECTED RESULTS ON PT/INR CARTRIDGES COMPARED TO LAB INSTRUMENT. THERE WAS NO PATIENT INFORMATION AVAILABLE. THE PATIENT WAS TREATED ON THE LAB RESULT.DATE TIME METHOD PT/ INR SAMPLE(B)(6) 2013 09:34 I-STAT 5.1 A(B)(6) 2013 09:25 STAGO 3.5 BBASED 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
    567458 I-STAT PT/INRCARTRIDGE PT/INR CARTRIDGE GJS ABBOTT POINT OF CARE NA C13195

    Patients

    Seq Age Sex Outcome Treatment
    1