BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ ANALYZER

    MDR report key: 22108621 · Received May 29, 2025

    Report

    Report Number
    2919069-2025-00022
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    March 28, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PERFORMED AN AUTO CLEAN PROCEDURE THAT RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE FLOW CYTOMETRY STANDARD (FCS) FILES AND SPECIMEN RESULTS WERE REVIEWED. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY HQ PROCESSING MODULE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE FOR SERIAL HQ01198 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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 DEPRESSED HEMOGLOBIN (HGB) RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR FIVE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 SID (B)(6). HGB 5.65 G/DL. REPEATED ON ANOTHER INSTRUMENT. HGB 9.4 G/DL. SID (B)(6). HGB 4.63 G/DL. REPEATED ON ANOTHER INSTRUMENT. HGB 8.9 G/DL. SID (B)(6). HGB 7.3 G/DL. REPEATED ON ANOTHER INSTRUMENT. HGB 14.5 G/DL. SID (B)(6). HGB 5.05 G/DL. WBC 2.15. REPEATED ON ANOTHER INSTRUMENT. HGB 8.5 G/DL. WBC 0.30. SID (B)(6). HGB 7.97 G/DL. REPEATED ON ANOTHER INSTRUMENT. HGB 13.9 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED HEMOGLOBIN (HGB) RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR FIVE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6), HGB 5.65 G/DL. REPEATED ON ANOTHER INSTRUMENT HGB 9.4 G/DL. SID (B)(6), HGB 4.63 G/DL. REPEATED ON ANOTHER INSTRUMENT HGB 8.9 G/DL. SID (B)(6) HGB 7.3 G/DL. REPEATED ON ANOTHER INSTRUMENT HGB 14.5 G/DL. SID (B)(6) HGB 5.05 G/DL, WBC 2.15. REPEATED ON ANOTHER INSTRUMENT HGB 8.5 G/DL WBC 0.30. SID (B)(6) HGB 7.97 G/DL. REPEATED ON ANOTHER INSTRUMENT HGB 13.9 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567765 ALINITY HQ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown