BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 4100076 · Received September 18, 2014

    Report

    Report Number
    2245578-2014-00049
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 20, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 10/10/2014. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION. RETAIN CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    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 0.66 ON A FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.DATE: (B)(6) 2014TIME INSTRUMENT CTNI SAMPLE1800 I-STAT 0.04 A1924 I-STAT 0.66 BDATE (B)(6) 201402:49 ROCHE LESS THAN 0.03 CTHERE WERE NO INJURIES REPORTED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577849 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA P14086A

    Patients

    Seq Age Sex Outcome Treatment
    1