BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE BLOOD COLLECTION TUBES SERUM PRODUCT GROUP

    MDR report key: 17821605 · Received September 26, 2023

    Report

    Report Number
    1125230-2023-00057
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Report Date
    September 26, 2023
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K983952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT (B)(4): NO SAMPLES WERE RECEIVED FOR EVALUATION. NO MATERIAL NUMBERS WERE PROVIDED BY THE CUSTOMER. NO BATCH NUMBERS WERE PROVIDED BY THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER ADVISED THEY EXPERIENCED SEVERAL REPORTS OF INCREASED POTASSIUM LEVELS. THE CUSTOMER REQUESTED TROUBLESHOOTING ASSISTANCE FROM GBO TO ADDRESS ANY PREANALYTIC CONCERNS WITH THE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440943 VACUETTE BLOOD COLLECTION TUBES SERUM PRODUCT GROUP EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown