BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 4053429 · Received September 3, 2014

    Report

    Report Number
    2245578-2014-00046
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 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 09/05/2014. RETURN AND RETAIN CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2014, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 0.28 ON A 53 YEAR OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.DATE TIME METHOD RESULT SAMPLE(B)(6) 2014 06:43 I-STAT 0.28 A(B)(6) 2014 07:03 I-STAT 0.00 A (REPEAT)(B)(6) 2014 08:00 I-STAT 0.00 C(B)(6) 2014 UNK I-STAT 0.00 C (REPEAT)(B)(6) 2014 06:35 LAB CPK:147 B (CPK 49-397)THERE WERE NO INJURIES REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539391 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA P14136

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR