BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 4025115 · Received August 20, 2014

    Report

    Report Number
    2245578-2014-00043
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 09/08/2014. RETAIN CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 0.49 ON A PATIENT WHO PRESENTED WITH CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.DATE SAMPLE DRAW TIME RESULT TIME METHOD RESULT (NG/ML) SAMPLE(B)(6) 2014 10:23 10:28 I-STAT 0.49 A(B)(6) 2014 10:23 10:43 I-STAT 0.02 A(B)(6) 2014 10:42 10:52 I-STAT 0.04 BTHERE WERE NO INJURIES REPORTED WITH THIS EVENT. AN INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503356 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA P14136

    Patients

    Seq Age Sex Outcome Treatment
    1