BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCKESSON CONSULT U120

    MDR report key: 8299480 · Received February 1, 2019

    Report

    Report Number
    2531491-2019-00001
    Event Type
    Injury
    Date Received
    February 1, 2019
    Report Date
    January 3, 2019
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    JRE
    PMA / PMN Number
    K120124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTING OF THIS CASE IS BASED ON A CALL RECEIVED FROM A DOCTOR'S OFFICE IN (B)(6) WHO WAS HAVING ISSUES WITH THEIR URINE ANALYZER. CUSTOMER REPORTED THAT THEIR ANALYZER WAS READING NEGATIVE FOR LEUKOCYTES BUT THE PATIENT WAS HOSPITALIZED THE NEXT DAY DUE TO SEPSIS AS A RESULT OF UTI. IN FOLLOW UP COMMUNICATION FOR THIS CASE, THE CUSTOMER CLARIFIED THAT THE LAB RESULT WAS NEGATIVE FOR INFECTION. ACCORDING TO THE CUSTOMER, THE CULTURE WAS DRAWN UP WITHIN MINUTES AND SENT TO THE LAB ON THE SAME DAY. CUSTOMER REPORTED THAT HOSPITALIZED PATIENT WAS TREATED AT THE HOSPITAL AND IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91170 MCKESSON CONSULT U120 URINE ANALYZER JRE ACON LABORATORIES, INC. U120

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization