BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUN

    MDR report key: 14521989 · Received May 26, 2022

    Report

    Report Number
    MW5109950
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Report Date
    May 26, 2022
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Product Code
    CDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING COMPLAINT HANDLING, A CUSTOMER (B)(6) REPORTED PRODUCT FAILURE. CAROLINA LIQUID CHEMISTRIES CORP.¿S RETENTION SAMPLE FAILED QUALITY CONTROL AND THE LEAD RESEARCH ASSOCIATE REPLACED THE MEDICAL DEVICE WITH ANOTHER COMPANY¿S MEDICAL DEVICE AND SENT IT TO THE CUSTOMER AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160748 BUN UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN CDQ CAROLINA LIQUID CHEMISTRIES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown