BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT PROFILE PRIME CCS ANALYZER WITH SCANNER 2

    MDR report key: 6651879 · Received June 19, 2017

    Report

    Report Number
    1219029-2017-00006
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    May 18, 2017
    Report Date
    May 22, 2017
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    GKF
    PMA / PMN Number
    K141907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CUSTOMER COMPLAINT INFORMATION CONFIRMED THAT THE PATIENT WAS NOT MISTREATED DUE TO THE IDENTIFIED SOFTWARE ISSUE. NOVA HAS ALSO CONFIRMED THAT THIS IS THE FIRST COMPLAINT THAT WE HAVE RECEIVED DUE TO THIS REPORTED SOFTWARE ISSUE. DECISION TO INITIATE A FIELD CORRECTION TO IMMEDIATELY CORRECT THE SOFTWARE ISSUE ASSOCIATED WITH THE USE OF STAT PROFILE PRIME AUTO-CARTRIDGE QUALITY CONTROL (A-QC) MATERIALS. THE INVESTIGATION IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    PRIME ANALYZER S/N (B)(4) FAILING TO FLAG A PATIENT CRITICAL PH LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432520 STAT PROFILE PRIME CCS ANALYZER WITH SCANNER 2 ANALYZER GKF NOVA BIOMEDICAL CORPORATION 53657

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR