BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON CONSULT 120 URINE ANALYZER

    MDR report key: 21719971 · Received March 28, 2025

    Report

    Report Number
    2531491-2025-00091
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    March 24, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    KQO
    PMA / PMN Number
    K120124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS FOLLOW-UP REPORT, THE FOLLOWING INFORMATION IS DIFFERENT THAN THE INITIAL REPORT. B4: DATE OF THIS REPORT D9: IS THIS DEVICE AVAILABLE FOR EVALUATION? G6: TYPE OF REPORT H2: IF FOLLOW-UP, WHAT TYPE? H6: ADVERSE EVENT PROBLEM. THE FINAL INVESTIGATION YIELDED THE FOLLOWING CONCLUSION: FINAL PRODUCT MANUFACTURE AND QC RECORDS FOR 210126 WERE REVIEWED AND NO ABNORMAL ISSUE WAS FOUND IN MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS IS COMPLIED WITH DMR. AFTER MULTIPLE ATTEMPTS TO CONTACT, CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION TO CONTINUE INVESTIGATION.

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULT(S). CUSTOMER REPORTING THAT THE ANALYZER IS READING NEGATIVE BUT THE VISUAL READ IS POSITIVE FOR BLOOD AND LEU (+1). THEY WERE UNABLE TO PROVIDE A PICTURE. THEY HAVE RUN CONTROLS AND THEY PASS. THEY DO CLEAN THE STRIP TRAY OFTEN. LED VALUES ARE 3325 3471 0162, 3063 2965 0161, 0232 0240 0161. THE STRIPS WERE OPENED A COUPLE DAYS AGO

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULT(S). CUSTOMER REPORTING THAT THE ANALYZER IS READING NEGATIVE BUT THE VISUAL READ IS POSITIVE FOR BLOOD AND LEU (+1). THEY WERE UNABLE TO PROVIDE A PICTURE. THEY HAVE RUN CONTROLS AND THEY PASS. THEY DO CLEAN THE STRIP TRAY OFTEN. LED VALUES ARE 3325 3471 0162, 3063 2965 0161, 0232 0240 0161. THE STRIPS WERE OPENED A COUPLE DAYS AGO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693335 MCKESSON CONSULT 120 URINE ANALYZER URINE ANALYZER KQO ACON LABORATORIES, INC. URS4100117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown