BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ ANALYZER

    MDR report key: 24792819 · Received April 6, 2026

    Report

    Report Number
    3016438761-2026-00195
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED NEUTROPHIL RESULTS GENERATED BY THE ALINITY HQ ANALYZER ON A PATIENT. THE RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE SAMPLES WERE REPEATED, YIELDING HIGHER RESULTS ON ANOTHER 2 ANALYZERS AND MANUAL DIFFERENTIAL COUNT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), 87 YEARS OLD MALE; INITIAL RESULTS 0.20 X 10E3/ L, REPEAT RESULTS FROM OTHER ANALYZERS WERE (SEQ # (B)(6)) WAS 6.38 X 10E3/ L & (SEQ # (B)(6)) WAS 6.57 X 10E3/ L. THE DIFFERENT MANUAL COUNT RESULTS WERE 56%. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849864 ALINITY HQ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male