BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMSTRIP 10 MD URINE TEST STRIPS

    MDR report key: 23880456 · Received December 23, 2025

    Report

    Report Number
    1823260-2025-05329
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 5, 2025
    Report Date
    March 3, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LJX
    PMA / PMN Number
    K032437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S TEST STRIPS WERE NOT AVAILABLE FOR INVESTIGATION. THE TEST STRIP RETENTION MATERIAL OF THE SAME LOT AND LOT 87840600 WERE TESTED ON A RETENTION URISYS 1100 ANALYZER WITH 0-NATIVE-URINE AND A LEUKOCYTES DILUTION SERIES. ALL RETENTION MATERIALS SHOW NO FALSE NEGATIVE RESULTS AND FULFILL REQUIREMENTS. NO FURTHER COMPLAINTS WERE RECEIVED RELATED TO THE TEST STRIP LOTS. A CONTAMINATION INSIDE THE METER CAUSING UNEXPECTED RESULTS CANNOT BE EXCLUDED. AN ANALYZER ISSUE IS UNLIKELY SINCE IT PASSED CALIBRATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT LEUKOCYTE TEST STRIP RESULTS FOR ONE PATIENT SAMPLE TESTED ON A URISYS 1100 SYSTEM (SERIAL NUMBER (B)(6)). THE SAMPLE INITIALLY RESULTED IN A NEGATIVE LEUKOCYTE VALUE. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 100 LEUKOCYTES/UL. THE SAMPLE WAS EVALUATED VIA MANUAL MICROSCOPY AND IT RESULTED IN A LEUKOCYTE VALUE OF 500 LEUCOCYTES/UL. THE MICROSCOPY VALUE WAS DEEMED CORRECT BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321684 CHEMSTRIP 10 MD URINE TEST STRIPS URINE TEST STRIPS LJX ROCHE DIAGNOSTICS 85395206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown