BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 17985443 · Received October 23, 2023

    Report

    Report Number
    2919069-2023-00043
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 13, 2023
    Report Date
    June 26, 2024
    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 FIELD SERVICE REPRESENTATIVE (FSR) CHECKED OPTICS FOR LEAKAGE. S1 AND S2 TUBINGS FROM NOZZLE TO INJECTION MANIFOLD WERE REPLACED, AS WELL AS TUBING FROM THE INJECTION MANIFOLD TO THE WBC AND RBC STAGING PUMPS. CHECK VALVES FOR BUBBLE MIXING IN BOTH WBC CUPS AND TUBING IN DRAIN PINCH VALVES WERE REPLACED. THE CHECK VALVE AFTER V09 AND AFTER THE WASTE ASP/DISP CHAMBER WERE PROACTIVELY REPLACED. REPLACEMENT OF VALVES V55 AND V57 IN THE SAMPLING SWITCHING MANIFOLD IS WHAT RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF CUSTOMER DATA ALIGNED WITH THE CUSTOMER¿S ISSUE AND NO ADDITIONAL ISSUES WERE IDENTIFIED. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(4).THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING FOR THE ASSY, VALVE, LVM09, 2/2 N.C., 24VDC DID NOT IDENTIFY ANY TRENDS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE FOR SERIAL (B)(6) OR THE ASSY, VALVE, LVM09, 2/2 N.C., 24VDC WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    CORRECTION WAS MADE TO FIELD D2B PRO CODE. THE INCORRECT CODE OF GRZ WAS CHANGED TO GKZ. THIS WAS A TYPOGRAPHICAL ERROR CORRECTION AND THERE IS NO FURTHER IMPACT TO THE SUBMISSION. ADDITIONAL INFORMATION PROVIDED IN D4 PRIMARY UDI NUMBER:(B)(4).(B)(6).

    Additional Manufacturer Narrative · 0

    COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: (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 DEPRESSED WBC RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE ((B)(6)) FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): (B)(6) RESULT = 8.96 K/UL, (B)(6) RESULT = 51.9 K/UL ADDITIONAL LABORATORY DATA WAS PROVIDED: (B)(6) GENERATED DATA INVALIDATING FLAGS FOR NEUTROPHILS, LYMPHOCYTES, EOSINOPHILS, BASOPHILS, AND IG DIFFERENTIAL RESULTS. THE DISCREPANT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED WBC RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE (B)(6) FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) : (B)(6) RESULT = 8.96 K/UL, (B)(6) RESULT = 51.9 K/UL ADDITIONAL LABORATORY DATA WAS PROVIDED: (B)(6) GENERATED DATA INVALIDATING FLAGS FOR NEUTROPHILS, LYMPHOCYTES, EOSINOPHILS, BASOPHILS, AND IG DIFFERENTIAL RESULTS. THE DISCREPANT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED WBC RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE (HQ00939) FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID 022823101330: HQ00939 RESULT = 8.96 K/UL, HQ00926 RESULT = 51.9 K/UL ADDITIONAL LABORATORY DATA WAS PROVIDED: HQ00939 GENERATED DATA INVALIDATING FLAGS FOR NEUTROPHILS, LYMPHOCYTES, EOSINOPHILS, BASOPHILS, AND IG DIFFERENTIAL RESULTS. THE DISCREPANT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447231 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    1981286 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown