BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 19733313 · Received July 12, 2024

    Report

    Report Number
    2919069-2024-00044
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    July 4, 2024
    Report Date
    October 14, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF PRODUCT HISTORICAL DATA FOR ANY TRENDS AND ALL CUSTOMER COMPLAINTS RECEIVED FOR THIS ISSUE DID NOT IDENTIFY ANY TRENDS OR INCREASE IN COMPLAINT ACTIVITY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE FIELD SERVICE REPRESENTATIVE (FSR) CLEANED THE WBC STAGING LINE WITH THE ENZYMATIC CLEANER. THE CHECK VALVES AND WBC STAGING PUMP WERE ALSO REPLACED PROACTIVELY, RESOLVING THE ISSUE. REVIEW OF THE DATA FOUND SEQ 609688 WAS FLAGGED AS OUT OF RANGE (OOR) LOW FOR THE LYM PARAMETER AND OOR HIGH FOR THE %BASO PARAMETER. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER SEQ 609734 AND GENERATED A OOR LOW FLAG FOR THE WBC, NEU, AND LYM PARAMETERS. THE NRBC AND NR/W PARAMETERS WERE ALSO FLAGGED AS INVALID FOR THE RUN. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE, LIST NUMBER 09P68, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULES ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2024 SID (B)(6) INITIAL=2.86 10E3/UL /REPEATED=0.957 10E3/UL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULES ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2024 SID (B)(6). INITIAL=2.86 10E3/UL /REPEATED=0.957 10E3/UL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142908 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown