BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 19489550 · Received June 7, 2024

    Report

    Report Number
    2919069-2024-00038
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    June 3, 2024
    Report Date
    August 15, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CORRECTION WAS MADE TO FIELD D2B PRO CODE. THE INCORRECT CODE OF GRZ WAS CHANGED TO CORRECT CODE GKZ. THIS WAS A TYPOGRAPHICAL ERROR CORRECTION. UPDATED INFORMATION IN SECTION D4 PRIMARY UDI NUMBER TO (B)(4). THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED AND DETERMINED THE FAILURE TO DRAIN THE WBC CUP, CAUSING OVER DILUTION. THE FSR REPLACED VALVE #13, DRAIN VALVE WBC #1, PINCH VALVE, 2-WAY NC, 24VDC, LIST H-35007085-02, WHICH RESOLVED THE ISSUE. THE REVIEW DID NOT IDENTIFY ANY ADVERSE TRENDS OR ABNORMAL COMPLAINT ACTIVITY. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSED THE ISSUE UNDER REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE PRODUCT HISTORICAL DATA DID NOT FIND A PRODUCT ISSUE RELATED TO THE COMPLAINT INCIDENT. 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 WHITE BLOOD CELL (WBC) RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE:ON (B)(6) 2024 SID (B)(6) INITIAL=9.98 10E9/L /REPEATED=146.0 10E9/LLABORATORY REFERENCE RANGE FOR WBC=4.0 TO 10.0 10E9/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED WHITE BLOOD CELL (WBC) RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON 03JUN2024 SID (B)(6), INITIAL=9.98 10E9/L /REPEATED=146.0 10E9/L LABORATORY REFERENCE RANGE FOR WBC=4.0 TO 10.0 10E9/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639552 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    2319230 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown