BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE 120 MINI URINE ANALYZER

    MDR report key: 17801368 · Received September 22, 2023

    Report

    Report Number
    2531491-2023-00681
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 18, 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 190628 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 FEEDBACK, FIRST WE ASKED THE CUSTOMER TO PROVIDE MORE INFORMATION FOR FURTHER INVESTIGATION. ON DEC 14, WE CHECKED THE ANALYZER LEDS STATUS, AND FOUND BOTH OF THE LEDS WERE NORMAL. THE SETUP VALUE OF RED LED IS 3477 AND THE ACTUAL DATA IS 3419; THE SETUP VALUE OF GREEN LED IS 3576 AND THE ACTUAL DATA IS 3520 THE ANALYZER STATUS WAS OK. AFTER CHECKING THE FREQUENCY AND VISUAL READING, THE ISSUE WAS REPRODUCED. THE ANALYZER STATUS WAS OK, BUT THE ISSUE WAS REPRODUCED. WE ARE NOT SURE ABOUT THE ROOT CAUSE.

    Description of Event or Problem · 0

    INACCURATE TEST RESULTS. THE ANALYZER READINGS AND VISUAL READINGS ARE NOT WITHIN +/- 1 COLOR BLOCK DIFFERENCE OF EACH OTHER. THE CUSTOMER CONFIRMED THEY RUN QUALITY CONTROLS (PART# U021-011, LOT# UCL2090012, EXP 07/20/2024) WEEKLY WITH CORRECT STRIPS (PART# MPHUA10SG, LOT# 98122100008, EXP 12/28/2024, OPENED 09/13/2023).

    Description of Event or Problem · 0

    INACCURATE TEST RESULTS. THE ANALYZER READINGS AND VISUAL READINGS ARE NOT WITHIN +/- 1 COLOR BLOCK DIFFERENCE OF EACH OTHER. THE CUSTOMER CONFIRMED THEY RUN QUALITY CONTROLS (PART# U021-011, LOT# UCL2090012, EXP 07/20/2024) WEEKLY WITH CORRECT STRIPS (PART# MPHUA10SG, LOT# 98122100008, EXP 12/28/2024, OPENED (B)(6) 2023).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561725 MEDLINE 120 MINI URINE ANALYZER URINE ANALYZER KQO ACON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown