BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIS LABORATORY INSTRUMENT

    MDR report key: 17534725 · Received August 12, 2023

    Report

    Report Number
    MW5141625
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    July 10, 2012
    Report Date
    August 17, 2012
    Manufacturer
    BECKMAN COULTER
    Product Code
    KQO
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IN ACCORDANCE WITH 21 CFR 803.22 (B)(2), WE ARE NOTIFYING YOU THAT ON JULY 17, 2012, A CUSTOMER CONTACTED ROCHE DIAGNOSTICS AND REPORTED AN INCIDENT THAT OCCURRED ON (B)(6), 2012. HOSPITAL CUSTOMER REPORTED THAT A SINGLE PATIENT SAMPLE RETURNED NEGATIVE (LESS THAN 25/ML) RESULTS FOR LEUKOCYTES ON SEVEN SEPARATE URISYS 1100 INSTRUMENTS WHILE AN IRIS LABORATORY INSTRUMENT RETURNED RESULTS OF 1 + (250-500/ML). NO TREATMENT OR ADVERSE EVENT RELATED TO THESE READINGS WAS REPORTED. THE IRIS LABORATORY INSTRUMENT MENTIONED IN THIS EVENT IS NOT MANUFACTURED OR IMPORTED BY OUR FIRM. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728031 IRIS LABORATORY INSTRUMENT AUTOMATED URINALYSIS SYSTEM KQO BECKMAN COULTER

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown