BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON CONSULT 120 URINE ANALYZER

    MDR report key: 8984947 · Received September 10, 2019

    Report

    Report Number
    2531491-2019-00002
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    June 18, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    JRE
    UDI-DI
    10612479210278
    PMA / PMN Number
    K120124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INTENDED AS A FOLLOW UP TO INITIAL REPORT 2531491-2019-00002. HOWEVER, UPON ATTEMPT TO SUBMIT FOLLOW UP ON 09/10/2019, IT WAS FOUND THAT THE INITIAL REPORT FROM 07/17/2019 FAILED TRANSMISSION TO FDA ESG. THEREFORE, THIS REPORT IS BEING SUBMITTED AS AN INITIAL REPORT AND DOCUMENTED EVIDENCE OF ATTEMPT TO SUBMIT MEDWATCH 3500A FORM DURING INITIAL 30DAY REPORTING PERIOD HAS BEEN ATTACHED. DURING THE PERIOD OF TIME BETWEEN THE INITIAL REPORT AND THIS FOLLOW UP REPORT, NO ADDITIONAL INFORMATION WAS RECEIVED TO CHANGE ANY INFORMATION CONTAINED IN THE REPORT DATED JULY 17, 2019 REGARDING THE EVENT OR PATIENT CONDITION. IN THIS FOLLOW UP REPORT, THE FOLLOWING INFORMATION IS DIFFERENT FROM THE INITIAL REPORT AS EVALUATION OF THE DEVICE WAS COMPLETED: DEVICE EVALUATED BY MANUFACTURER: YES (EVALUATION HAD NOT BEEN COMPLETED AT TIME OF INITIAL REPORT).

    Description of Event or Problem · 1

    URGENT CARE REPORTED THAT THEY HAD A PATIENT PRESENT WITH UTI SYMPTOMS, BUT THE URINE ANALYZER WAS SHOWING FALSE NEGATIVE RESULTS FOR LEUKOCYTES. WHEN THE SAME SAMPLE WAS READ VISUALLY WITH A NEW STRIP, THERE WAS MORE THAN 1 COLOR BLOCK DIFFERENCE BETWEEN THE ANALYZER AND VISUAL READ RESULTS. THE ANALYZER WAS NEGATIVE FOR LEUKOCYTES AND VISUALLY WAS A 2+. THE CUSTOMER HAS NOT TAKEN ANY MEDICATIONS THAT COULD INTERFERE WITH THE TEST, AND THE STRIPS WERE NOT DISCOLORED OUT OF THE CONTAINER. THE URGENT CARE HAS TRIED 2 DIFFERENT CANISTERS OF STRIPS OF THE SAME LOT AND THE RESULTS ARE THE SAME. THE CONTROLS WERE NOT EXPIRED AND WERE STORED PROPERLY IN THE FRIDGE, AND WHEN TESTED THEY PASSED FOR STRIPS FROM BOTH CANISTERS. THE SAMPLE HAS ALSO BEEN RE-TESTED AND THE RESULTS ARE THE SAME (ANALYZER NEGATIVE FOR LEUKOCYTES AND VISUAL READ POSITIVE FOR LEUKOCYTES). THE URGENT CARE HAS REPORTED THAT THEY CLEAN THE STRIP TRAY REGULARLY AND HAVE ALSO CLEANED THE HEXAGONAL HEAD. PICTURES WERE PROVIDED SHOWING THE VISUAL READ RESULTS COMPARED TO THE ANALYZER. PATIENT HAS SIGNS OF UTI BUT THERE IS NO REPORT OF INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774356 MCKESSON CONSULT 120 URINE ANALYZER URINE ANALYZER JRE ACON LABORATORIES, INC. U120 10612479210278

    Patients

    Seq Age Sex Outcome Treatment
    1 Other