BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 5669695 · Received May 20, 2016

    Report

    Report Number
    2245578-2016-00029
    Event Type
    Malfunction
    Date Received
    May 20, 2016
    Date of Event
    April 27, 2016
    Report Date
    July 7, 2016
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 06/22/2016. CUSTOMER RETURNS AND RETAIN PRODUCT WAS TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) MALE PATIENT ADMITTED FOR VOMITING. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT THE PATIENT WAS TREATED ON THE REPEAT OF THE I-STAT RESULTS AND PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE SAMPLE TIME TEST TIME NA CL SAMPLE DATE: (B)(6)2016, SAMPLE TIME: 0240, TEST TIME: 0246, NA: 120, CL: >140, SAMPLE: A.; ON (B)(6) 2016, N/A, N/A, 143, 104, N/A. 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
    325353 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H16008

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR