BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 10347602 · Received July 30, 2020

    Report

    Report Number
    2939693-2020-00078
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 9, 2019
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    UDI-DI
    EABA1100000001
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON -(B)(6) 2019, ABAXIS RECEIVED A CALL FROM THE CUSTOMER LAB STATING THAT THE DEVICE YIELDED UNEXPECTED HIGH SODIUM RESULTS. THE CUSTOMER DID NOT RESPOND TO ANY FOLLOW UP ATTEMPTS FOR GATHERING OF INFORMATION AND DATA. THE CALL WAS CLOSED TO CAPA (B)(4). THIS REPORT WAS NOT SUBMITTED PREVIOUSLY AND IS BEING SUBMITTED AS A RESULT OF A THREE (3) YEAR RETROSPECTIVE REVIEW OF CLOSED COMPLAINTS ABAXIS PERFORMED AS PART OF ITS COMMITMENT TO CORRECT THE FDA-483 OBSERVATIONS RECEIVED ON (B)(6) 2019.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE YIELDED UNEXPECTED HIGH SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807172 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO ANALYZER JJG ABAXIS, INC. P24616 EABA1100000001

    Patients

    Seq Age Sex Outcome Treatment
    1