BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ 200 SYSTEM

    MDR report key: 7122687 · Received December 15, 2017

    Report

    Report Number
    2023446-2017-00012
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    June 11, 2015
    Report Date
    November 15, 2017
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K022774
    Removal / Correction Number
    2050012-0125/2018-005C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP 01: ADDITIONAL INFORMATION HAS BEEN SELECTED. RECALL, NOTIFICATION AND INSPECTION HAVE BEEN SELECTED. NUMBER HAS BEEN UPDATED TO REFLECT THE RESPECTIVE INFORMATION FOR THIS EVENT. THE RECALL (FA-32916) INCLUDES NOTIFICATION TO THE CUSTOMER AND CORRECTION OF THE ISSUE. BEC INTERNAL IDENTIFIER - (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015, THE IQ200 SELECT INSTRUMENT WAS VALIDATED FOR CUSTOMER USE BY A BECKMAN COULTER APPLICATION SPECIALIST. DURING VALIDATION, THE UNITS FOR CASTS WERE SET AS HPF. THE (BEC CTS) INFORMED THE CUSTOMER THAT BASED ON NORTH AMERICAN (NA) CUSTOMER GUIDE TO IQ®200 SERIES FORMED PARTICLE SETTINGS, PART NUMBER 300-5413 REV CB, CASTS ARE NORMALLY ENUMERATED AT LPF. ON 04-DEC-2017, THE BEC APPLICATION SPECIALIST ASSISTED THE CUSTOMER WITH CORRELATION STUDIES BASED ON THE CORRECTED LPF SETTINGS FOR CASTS WHICH CONFIRMED THAT MANUAL ENUMERATION AND AUTOMATED ENUMERATION RESULTS CORRELATED. THE CUSTOMER WAS SATISFIED WITH THE RESULTS AND HAS NOT REPORTED ANY FURTHER ISSUES ON THE INSTRUMENT. NO OTHER SETTINGS REQUIRED ADJUSTMENT DURING THE CUSTOMER CALL. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017 THE CUSTOMER CALLED SEEKING ASSISTANCE TO CHANGE THE UNIT SETTINGS FOR URINE CASTS FROM HIGH POWER FIELD (HPF) TO LOW POWER FIELD (LPF).ON THE IQ200 INSTRUMENT. VALIDATION RECORDS REFLECT THAT HPF SETTINGS WERE USED TO VALIDATE THE INSTRUMENT ON 11-JUNE-2015. THE CUSTOMER STATED THAT THERE HAVE BEEN NO KNOWN INSTANCES OF ERRONEOUS RESULTS BEING GENERATED OR REPORTED FROM THE LABORATORY AND AS SUCH THERE HAVE NO REPORTS OF CHANGE TO PATIENT MANAGEMENT. DURING THE CALL, THE BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT SPECIALIST (BEC CTS) IMMEDIATELY INSTRUCTED THE CUSTOMER TO CHANGE CAST ANALYTE UNITS TO LOW POWER FIELD (LPF). REPORTING CASTS IN HIGH POWER FIELD (HPF) AND NOT LOW POWER FIELD (LPF) CAN RESULT IN A LOWER VALUE THAN EXPECTED FOR CASTS. INSTRUMENT PRINTOUTS DO NOT DISPLAY THE UNITS FOR CASTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901596 IQ 200 SYSTEM AUTOMATED URINALYSIS SYSTEM KQO IRIS INTERNATIONAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1