BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CK-MB CARTRIDGE

    MDR report key: 5318887 · Received December 22, 2015

    Report

    Report Number
    2245578-2015-00071
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    December 19, 2015
    Report Date
    February 12, 2016
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MYT
    PMA / PMN Number
    K051433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 02/04/2016. CUSTOMER RETURNS AND RETAIN PRODUCT WAS TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION..

    Description of Event or Problem · 1

    ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CK-MB CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) MALE PATIENT WITH CANCER. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD:I-STAT, TIME:1545, CK-MB: 40.4, SAMPLE: A. I-STAT, 1730, 0.4, A; I-STAT, 2212, 0.2, B. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    NA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845326 I-STAT CK-MB CARTRIDGE CK-MB CARTRIDGE MYT ABBOTT POINT OF CARE NA G15242

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR