BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ ANALYZER

    MDR report key: 21347126 · Received February 10, 2025

    Report

    Report Number
    2919069-2025-00007
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 18, 2025
    Report Date
    February 10, 2025
    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

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TRENDING REVIEW AND LABELING REVIEW. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ALINITY HQ PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES RELATED TO THE CURRENT ISSUE. LABELING WAS FOUND TO BE ADEQUATE FOR THE COMPLAINT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED WBC RESULTS AND FALSELY ELEVATED NRBC RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR A 12-YEAR-OLD FEMALE PATIENT WHO WAS RECENTLY DIAGNOSED WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (T-ALL). ON SATURDAY, (B)(6)2025, BLOOD SAMPLES WERE COLLECTED FROM THIS PATIENT FOR THE DETERMINATION OF HEMOGLOBIN, LEUKOCYTES, AND PLATELETS. HOWEVER, THE HEMATOLOGY ANALYZER ERRONEOUSLY REPORTED THE PRESENCE OF NRBCS, WHICH WERE NOT PRESENT. AS A RESULT, THE WBC COUNT WAS REPORTED AS FALSELY LOW. THE ACTUAL LEUKOCYTE COUNT IN PERIPHERAL BLOOD WAS 44.2 × 10/L, BUT IT WAS REPORTED AS 19.2 × 10/L. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULTS: SID (B)(6). (B)(6). WBC 19.2 NEU 9.15X. LYM 6.82X. NRBC 25.2*. REPEAT RESULTS: SID (B)(6). (B)(6). WBC 44.2. NEU 9.38X. LYM 31.6X. NRBC 2.28. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870713 ALINITY HQ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female