BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ ANALYZER

    MDR report key: 24792555 · Received April 6, 2026

    Report

    Report Number
    3016438761-2026-00194
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 14, 2026
    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

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED PLATELET (PLT) WHEN PROCESSING ON THE ALINITY HQ PROCESSING MODULE. THE PATIENT IS A 35-YEAR-OLD FEMALE WITH ACUTE LEUKEMIA, RECENTLY UNDERGONE A TRANSPLANT. ON (B)(6) 2026, SID (B)(4) REPEATED SEVERAL TIMES GENERATED ALINITY HQ PLT OF 162, 154, 165, 179, 180, 177 10E3/UL. THE MPV VALUE AND DIFFERENTIAL WAS INVALID ON ALL RUNS. THE BLOOD SMEAR PLT ESTIMATE WAS 0-2 PLT/PMF PER FIELD EQUAL TO ABOUT 10-15,000 UL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600556 ALINITY HQ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female