BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ ANALYZER

    MDR report key: 21341106 · Received February 9, 2025

    Report

    Report Number
    2919069-2025-00006
    Event Type
    Malfunction
    Date Received
    February 9, 2025
    Date of Event
    January 21, 2025
    Report Date
    April 16, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, TICKET TRENDING REVIEW, AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. FLOW CYTOMETRY STANDARD (FCS) FILES AND SPECIMEN REPORTS WERE PROVIDED BY THE CUSTOMER. A REVIEW OF DATA FOUND THAT THE LEFT SHIFT FLAG WAS GENERATED FOR ALL SAMPLE RUNS. ADDITIONALLY, LYM, MONO, AND BASO RESULTS WERE FLAGGED AS SUSPECT, AND BLAST FLAG WAS GENERATED FOR SEQ 444105. A REVIEW OF THE FCS FILES FOUND THAT THE SCATTERPLOTS SHOWED NO SIGNIFICANT PATTERN DIFFERENCE BETWEEN ALL SAMPLE RUNS; HOWEVER, SEQ 192320 SHOWED SIGNIFICANTLY MORE EVENTS. THIS WAS LIKELY DUE TO A SAMPLE PREPARATION OR PNEUMATIC (ASPIRATION) ISSUE. BASED ON THE INFORMATION PROVIDED, THE RESULTS WERE FLAGGED, INDICATING THAT VERIFICATION OF THE RESULTS WAS REQUIRED. THE FALSELY ELEVATED WBC RESULTS MAY HAVE BEEN DUE TO A SAMPLE PREPARATION OR PNEUMATIC (ASPIRATION) ISSUE. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ALINITY HQ PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES AS DESCRIBED IN THIS COMPLAINT. ADDITIONALLY, THE REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY HQ PROCESSING MODULE, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED WBC RESULT GENERATED ON THE ALINITY HQ ANALYZER FOR A 1-YEAR-OLD PATIENT. THE SAMPLE WAS REPEATED, AND LOWER RESULTS WERE OBTAINED. THE CUSTOMER CONFIRMED THE WBC COUNT WITH A MANUAL SLIDE REVIEW, WHICH CONFIRM THE WBC RESULT OF APPROXIMATELY 35,000. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): (B)(6) 2025 SEQ# 192320 WBC RESULT (B)(6) = 53.3 X 10E3/L WITH LEFT SHIFT FLAG. (B)(6) 2025 SEQ# 192321 WBC RESULT (B)(6) = 36.0 X 10E3/L WITH LEFT SHIFT FLAG. (B)(6) 2025 SEQ# 444104 WBC RESULT (B)(6) = 35.9 X 10E3/L WITH LEFT SHIFT FLAG. (B)(6) 2025 SEQ# 444105 WBC RESULT (B)(6) = 35.8 X 10E3/L WITH LEFT SHIFT AND BLAST FLAG. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED WBC RESULT GENERATED ON THE ALINITY HQ ANALYZER FOR A 1-YEAR-OLD PATIENT. THE SAMPLE WAS REPEATED, AND LOWER RESULTS WERE OBTAINED. THE CUSTOMER CONFIRMED THE WBC COUNT WITH A MANUAL SLIDE REVIEW, WHICH CONFIRM THE WBC RESULT OF APPROXIMATELY 35,000. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): (B)(6) 2025 SEQ# 192320 WBC RESULT (B)(6) = 53.3 X 10E3/¿L WITH LEFT SHIFT FLAG. (B)(6) 2025 SEQ# 192321 WBC RESULT (B)(6) = 36.0 X 10E3/¿L WITH LEFT SHIFT FLAG. (B)(6) 2025 SEQ# 444104 WBC RESULT (B)(6) = 35.9 X 10E3/¿L WITH LEFT SHIFT FLAG. (B)(6) 2025 SEQ# 444105 WBC RESULT (B)(6) = 35.8 X 10E3/¿L WITH LEFT SHIFT AND BLAST FLAG. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903304 ALINITY HQ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Unknown