BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON CONSULT U120 URINE ANALYZER

    MDR report key: 18000110 · Received October 24, 2023

    Report

    Report Number
    2531491-2023-00714
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    October 20, 2023
    Report Date
    January 5, 2024
    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 FROM THE INITIAL REPORT AS THE INTERNAL INVESTIGATION WAS COMPLETED. THE FINAL INVESTIGATION YIELDED THE FOLLOWING CONCLUSION: FINAL PRODUCT MANUFACTURE AND QC RECORD FOR 210126 AND THE ORDER NUMBER OF THE UNIT IS (B)(4). NO ABNORMAL ISSUE WAS FOUND IN MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS IS COMPLIED WITH DMR. AFTER GOT THE COMPLAINT, WE FIRST ASKED THE CUSTOMER TO PROVIDE MORE INFORMATION FOR FURTHER INVESTIGATION. ON DEC 11, LAB GOT THE ANALYZER AND TESTED THREE TIMES WITH THE EFFECTIVE CONTROL SOLUTION. WE CHECKED THE ANALYZER LEDS STATUS, FOUND THAT BOTH OF THE LEDS WERE NORMAL, THE SETUP OF THE RED LED WAS 3297 AND THE ACTUAL DATA WAS 2247; THE SETUP OF THE GREEN LED WAS 3461 AND THE ACTUAL DATA WAS 2770.THE ANALYZER'S STATUS IS OK. CHECK THE RESULTS READING BY VISUAL AND THE TESTED FREQUENCY, WE THINK THE RESULTS ARE ALL CONSISTENT, AND NO ABNORMALITY IS FOUND. THE ISSUE IS NOT REPRODUCED. PLEASE SEE TECHNICAL EVALUATION. THE ISSUE IS NOT REPRODUCED WITH THE RETURNED ANALYZER, SO WE ARE NOT SURE ABOUT THE ROOT CAUSE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE ANALYZER WILL READ NEGATIVE BUT VISUAL READ IS POSITIVE FOR LEU. THEY E-MAILED PICTURE OF POSITIVE LEU RESULT ALONG WITH INSTRUMENT PRINTOUT OF LEU READING NEG. LED VALUES ARE: 3297 3461 0162, 2247 2770 0162, 0308 0292 0162. THEY DID CLEAN THE INSTRUMENT BUT ARE STILL GETTING THE DISCREPANCY.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE ANALYZER WILL READ NEGATIVE BUT VISUAL READ IS POSITIVE FOR LEU. THEY E-MAILED PICTURE OF POSITIVE LEU RESULT ALONG WITH INSTRUMENT PRINTOUT OF LEU READING NEG. LED VALUES ARE: 3297 3461 0162, 2247 2770 0162, 0308 0292 0162. THEY DID CLEAN THE INSTRUMENT BUT ARE STILL GETTING THE DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674290 MCKESSON CONSULT U120 URINE ANALYZER URINE ANALYZER KQO ACON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown