BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON CONSULT 120 URINE ANALYZER

    MDR report key: 21202539 · Received January 21, 2025

    Report

    Report Number
    2531491-2025-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    January 20, 2025
    Report Date
    March 7, 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. G6: TYPE OF REPORT. H2: IF FOLLOW-UP, WHAT TYPE? H6: ADVERSE EVENT PROBLEM. THE FINAL INVESTIGATION YIELDED THE FOLLOWING CONCLUSION: BATCH RECORDS FOR FINAL PRODUCT MANUFACTURE AND QC RECORD FOR 221205-1 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 THE INITIAL COMPLAINT WAS RECEIVED, THE CUSTOMER WAS ASKED TO PROVIDE ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION. ON FEB 5, THE CUSTOMER STATED THAT THE ANALYZER WAS NOT INTERFACED. THE CUSTOMER WAS THEN ASKED TO PROVIDE PICTURES BUT DID NOT PROVIDE ANY RESPONSE. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULT(S). THE CUSTOMER EXPLAINED THAT WHEN THEY PERFORMED THE URINE SAMPLE ON THE ANALYZER AND GOT NEGATIVE LEUKOCYTE RESULT. THEY RETESTED THE SAMPLE VISUALLY, SEVERAL TIMES AND GOT 1+ LEUKOCYTE. CUSTOMER PROVIDED A PICTURE OF THE ANALYZER RESULTS AND VISUAL RESULTS. THEY DID NOT HAVE LAB URINALYSIS RESULTS. CUSTOMER DID CONFIRM THE ANALYZER IS RUNNING AND PASSING BOTH QC LEVELS.

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULT(S). THE CUSTOMER EXPLAINED THAT WHEN THEY PERFORMED THE URINE SAMPLE ON THE ANALYZER AND GOT NEGATIVE LEUKOCYTE RESULT. THEY RETESTED THE SAMPLE VISUALLY, SEVERAL TIMES AND GOT 1+ LEUKOCYTE. CUSTOMER PROVIDED A PICTURE OF THE ANALYZER RESULTS AND VISUAL RESULTS. THEY DID NOT HAVE LAB URINALYSIS RESULTS. CUSTOMER DID CONFIRM THE ANALYZER IS RUNNING AND PASSING BOTH QC LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631127 MCKESSON CONSULT 120 URINE ANALYZER URINE ANALYZER KQO ACON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown