BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IQ200 URINE ANALYZER

    MDR report key: 14026109 · Received April 6, 2022

    Report

    Report Number
    2122870-2022-00018
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 6, 2022
    Manufacturer
    BECKMAN COULTER IRELAND INC.
    Product Code
    KQO
    UDI-DI
    10837461001256
    PMA / PMN Number
    K022774
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD APPLICATIONS SPECIALIST WAS AT THE CUSTOMER SITE AND OBSERVED THAT IN SOME CASES THE SAMPLE RESULTS DID NOT HAVE ANY LEUCOCYTES OR RED BLOOD CELLS. THE FIELD APPLICATIONS SPECIALIST STATED THAT THE ASSIGNABLE CAUSE OF THE ISSUE WAS DUE TO THE IQ200 SPRINT INSTRUMENT NOT ASPIRATING THE URINE CORRECTLY; THE FIELD APPLICATIONS SPECIALIST ALSO STATED THAT THE INSTRUMENT DID NOT GENERATE A ¿EMPTY SAMPLE ALARM¿ (NO PARTICLE DETECTED ALARM). TO RESOLVE THE ISSUE, THE FIELD APPLICATIONS SPECIALIST REPLACED THE SAMPLE FILTER. IN ADDITION, THE FIELD APPLICATIONS SPECIALIST INSTALLED IWARE SOFTWARE ON MARCH-24TH WITH AN OPERATOR-REVIEW RULE ON PATIENT SAMPLE RESULTS ¿IF RBC =0 AND WBC =0 AND ASP<100 THEN STOP.¿ BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ERRONEOUS FALSE-NEGATIVE PATIENT CYTOLOGY TEST-RESULTS FROM THEIR IQ200 SPRINT URINALYSIS INSTRUMENT. THE CUSTOMER STATED THAT A CULTURE WAS PERFORMED ON SOME PATIENT SAMPLES WITH FALSE-NEGATIVE CYTOLOGY RESULTS; THE CULTURE REVEALED A VERY HIGH NUMBER OF LEUKOCYTES ON THE QUESTIONED PATIENT SAMPLES. ERRONEOUS PATIENT TEST RESULTS WERE REPORTED OUTSIDE OF THE CUSTOMER¿S LABORATORY. ONE ERRONEOUS PATIENT TEST RESULTED IN THE DELAY OF ANTIBIOTIC TREATMENT FOR 24 HOURS FOR THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EVENT OCCURRING AS A RESULT OF THE DELAY IN TREATMENT. PATIENT DATA WAS REQUESTED BUT NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900051 IQ200 URINE ANALYZER AUTOMATED URINALYSIS SYSTEM KQO BECKMAN COULTER IRELAND INC. IQ200 SPRINT 2008 TESTED 10837461001256

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other