BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ ANALYZER

    MDR report key: 23051138 · Received September 15, 2025

    Report

    Report Number
    2919069-2025-00040
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 4, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING ON THE ALINITY HQ PROCESSING MODULE, SERIAL NUMBER (B)(6) AND REPLACED MULTIPLE PARTS FOR LEAKING, CLOGGED AND PROACTIVELY. THE REPLACEMENT OF THE VALVE-CHECK, INLINE, PPRO; VALVE ASSY, 2-WAY, N/C, EPDM SEAL, 24VDC, SMC LVM15; ASSY, WASTE BTL, 1L, FLOAT LEVEL SWITCH, PPRO; TUBING KIT 4, KIT S2109; AND FTG TBG VLV CHK .062 INCH DUCK BILL RESOLVED THE ISSUE. THE INSTRUMENT SERVICE HISTORY FOR THE ALINITY HQ PROCESSING MODULE VERIFIES NO SUBSEQUENT COMPLAINTS HAVE BEEN REPORTED RELATED TO DISCREPANT HEMOGLOBIN PATIENT RESULTS. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES RELATED TO THE ALINITY HQ AND CUSTOMER REPORTED EVENT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY HQ PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE VALVE-CHECK, INLINE, PPRO; VALVE ASSY, 2-WAY, N/C, EPDM SEAL, 24VDC, SMC LVM15; ASSY, WASTE BTL, 1L, FLOAT LEVEL SWITCH, PPRO; TUBING KIT 4, KIT S2109; AND FTG TBG VLV CHK .062 INCH DUCK BILL WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED NEUTROPHIL AND HEMOGLOBIN RESULTS GENERATED BY THE ALINITY HQ ANALYZER FOR TWO PATIENTS. THE RESULTS WERE RELEASED OUT OF THE LAB. THE SAMPLES WERE REPEATED YIELDING HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT (B)(6): ON (B)(6) 2025, SID: (B)(6): HGB: INITIAL RESULT = 5.56 G/DL, REPEAT RESULT = 10.6 G/DL. PATIENT (B)(6): ON (B)(6) 2025, SID: (B)(6): NEU: INITIAL RESULT = 0.472 X 10E3/L, REPEAT RESULT = 0.942 X 10E3/L. HGB: INITIAL RESULT = 6.52 G/DL (HGB INTERFERENCE FLAG), REPEAT RESULT = 14.1 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED NEUTROPHIL AND HEMOGLOBIN RESULTS GENERATED BY THE ALINITY HQ ANALYZER FOR TWO PATIENTS. THE RESULTS WERE RELEASED OUT OF THE LAB. THE SAMPLES WERE REPEATED YIELDING HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: (B)(6) 2025, SID (B)(6): HGB: INITIAL RESULT = 5.56 G/DL, REPEAT RESULT = 10.6 G/DL. PATIENT 2: (B)(6) 2025, SID (B)(6): NEU: INITIAL RESULT = 0.472 X 10E3/L, REPEAT RESULT = 0.942 X 10E3/L HGB: INITIAL RESULT = 6.52 G/DL (HGB INTERFERENCE FLAG), REPEAT RESULT = 14.1 G/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519094 ALINITY HQ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown