BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM URINE CHEMISTRY STRIPS

    MDR report key: 3431347 · Received October 21, 2013

    Report

    Report Number
    3431347
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Date of Event
    August 7, 2013
    Report Date
    October 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    MEDICAL TECHNOLOGISTS WORKING AT THE OFF-SITE LABORATORIES REPORTED A HIGHER-THAN-USUAL RATE OF TRACE-POSITIVE URINE LEUKOCYTE ESTERASE RESULTS. THIS TEST IS PERFORMED AS A URINE DIPSTICK USING ICHEM STRIPS, AND IS READ USING AN ICHEM AUTOMATED URINALYSIS READER. UPON HEARING THIS NEWS FROM THE OFF-SITE LABS, THE OFF-SITE LAB SUPERVISOR BEGAN CALLING THE DIPSTICK MANUFACTURER TO INQUIRE ABOUT THE CAUSE OF THE PROBLEM. FOR A WEEK, THE OFF-SITE LAB SUPERVISOR TRIED UNSUCCESSFULLY TO GET A SATISFACTORY RESPONSE FROM THE MANUFACTURER. IN THE MEANTIME, HE TRACKED THE FALSE POSITIVES TO TWO PARTICULAR LOTS OF ICHEM STRIPS. THESE STRIPS WERE PUT INTO USE AT OTHER LAB LOCATIONS ON (B)(6), (B)(6), AND (B)(6) 2013 RESPECTIVELY. AT THAT TIME, THE DECISION WAS MADE TO VISUALLY READ THE LEUKOCYTE ESTERASE OFF THE STRIP BECAUSE THAT GIVES THE CORRECT RESULT. THIS WAS VERIFIED BY AN EXPERIMENT IN THE MAIN LAB USING BOTH THE OLD AND NEW LOTS OF ICHEM STRIPS. THEREFORE, EFFECTIVE (B)(6) 2013, THE PROBLEM OF FALSE POSITIVE RESULTS WAS RESOLVED WITH THIS WORK-AROUND AND PATIENT RESULTS HAVE BEEN REPORTED CORRECTLY SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537943 ICHEM URINE CHEMISTRY STRIPS ICHEM URINE CHEMISTRY STRIPS JJW BECKMAN COULTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *