BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE URINALYSIS REAGENT STRIPS

    MDR report key: 22153153 · Received June 5, 2025

    Report

    Report Number
    2531491-2025-00121
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    February 3, 2025
    Report Date
    August 6, 2025
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    CDM
    PMA / PMN Number
    K061559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 98124030001 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 TEST RESULTS OF RETENTION SAMPLES FROM 98124030001 MET THE QC CRITERIA. IN HOUSE TESTING WAS PERFORMED WITH RETAINED STRIPS, NEGATIVE AND POSITIVE CONTROLS, SIEMENS MULTISTIX 10SG AND 20 CLINICAL SAMPLES. THE SPECIFIC GRAVITY PAD SHOWS CORRECT PERFORMANCE WHEN TESTED WITH URINE CONTROLS AND CLINICAL URINE SAMPLES. WE HAVE NOT FOUND THE COMPLAINT ISSUE WHEN COMPARING WITH SIEMENS MULTISTIX 10SG STRIPS, THE SG PAD SHOWS THE SAME AND CORRECT VALUE WHEN TEST BY VISUAL AND BY ANALYZER. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2025 THE CUSTOMER NOTIFIED MEDLINE STATING THE SOLUTION IN THE KIT TESTING FOR SPECIFIC GRAVITY YIELDED A POSITIVE RESULT WHEN COMPLETING QA VERIFICATION TESTING. THEY ALSO REPORTED AN INSTANCE OF A URINE STRIP TEST THAT YIELDED A FALSE NEGATIVE RESULT THAT WAS TESTING FOR SPECIFIC GRAVITY CONCENTRATION ON THE PATIENT. THE FALSE NEGATIVE LEAD TO AN MDR EVENT AND CAUSED THE CLIENT TO HAVE SEVERE UTI SYMPTOMS.

    Description of Event or Problem · 0

    ON (B)(6) 2025 THE CUSTOMER NOTIFIED MEDLINE STATING THE SOLUTION IN THE KIT TESTING FOR SPECIFIC GRAVITY YIELDED A POSITIVE RESULT WHEN COMPLETING QA VERIFICATION TESTING. THEY ALSO REPORTED AN INSTANCE OF A URINE STRIP TEST THAT YIELDED A FALSE NEGATIVE RESULT THAT WAS TESTING FOR SPECIFIC GRAVITY CONCENTRATION ON THE PATIENT. THE FALSE NEGATIVE LEAD TO AN MDR EVENT AND CAUSED THE CLIENT TO HAVE SEVERE UTI SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603691 MEDLINE URINALYSIS REAGENT STRIPS URINALYSIS REAGENT STRIPS CDM ACON LABORATORIES, INC. 98124030001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other