BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY UROCHECK U120C URINE ANALYZER

    MDR report key: 22905304 · Received August 27, 2025

    Report

    Report Number
    2531491-2025-00164
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    July 29, 2025
    Report Date
    October 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. 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 U5020122 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. THE COMPLAINT IS NOT VERIFIED.

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULT(S). THE PATIENT THEY NOTICED THIS ISSUE WITH HAS ACUTE LIVER FAILURE. HOWEVER, THE UROCHECK 120C SHOWED THE BIL RESULT AS NEGATIVE. THEY TOOK A PICTURE OF THE RESULT NEXT TO THE STRIP BOTTLE, AND IT SEEMS TO INDICATE A POSITIVE RESULT (ALTHOUGH THIS WOULD BE PAST THE VISUAL READ TIME ON THAT SPECIFIC REAGENT PAD). THIS INSTANCE OCCURRED WITH THE LOT U5020122 OF DTG-10SG. THE UROCHECK 120C IS PASSING ITS DAILY QCS ON THAT SAME LOT OF STRIPS. THE STRIPS ARE NOT DISCOLORED AND HAVE BEEN OPENED WITHIN THE LAST COUPLE OF WEEKS.

    Description of Event or Problem · 0

    FALSE NEGATIVE RESULT(S). THE PATIENT THEY NOTICED THIS ISSUE WITH HAS ACUTE LIVER FAILURE. HOWEVER, THE UROCHECK 120C SHOWED THE BIL RESULT AS NEGATIVE. THEY TOOK A PICTURE OF THE RESULT NEXT TO THE STRIP BOTTLE, AND IT SEEMS TO INDICATE A POSITIVE RESULT (ALTHOUGH THIS WOULD BE PAST THE VISUAL READ TIME ON THAT SPECIFIC REAGENT PAD). THIS INSTANCE OCCURRED WITH THE LOT U5020122 OF DTG-10SG. THE UROCHECK 120C IS PASSING ITS DAILY QCS ON THAT SAME LOT OF STRIPS. THE STRIPS ARE NOT DISCOLORED AND HAVE BEEN OPENED WITHIN THE LAST COUPLE OF WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405184 CLARITY UROCHECK U120C URINE ANALYZER URINE ANALYZER KQO ACON LABORATORIES, INC. U5020122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown