BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 19339619 · Received May 17, 2024

    Report

    Report Number
    2919069-2024-00036
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 30, 2024
    Report Date
    August 15, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION D2B - PROCODE: CORRECTED FROM GRZ TO GKZ. ADDITIONAL INFORMATION SECTION D10 - CONCOMITANT PRODUCT AND H4 - DEVICE MFG DATE. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND REPLACED SEVERAL PARTS INCLUDING THE SHEATH FILTER, FILTER VENTED 0.45UM, WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING FOR THE SHEATH FILTER, FILTER VENTED 0.45UM DID NOT IDENTIFY ANY TRENDS. 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 (B)(6), OR THE SHEATH FILTER, FILTER VENTED 0.45UM WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS(B)(6) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HGB RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT RUN ON (B)(6), REPEAT ON (B)(6). (B)(6) 2024 SAMPLE ID (B)(6) HGB INITIAL RESULT = 56.2 G/L, REPEAT = 112 G/L. SAMPLE ID (B)(6) HGB INITIAL RESULT = 73.5 G/L, REPEAT = 114 G/L. SAMPLE ID (B)(6) HGB INITIAL RESULT = 53.9 G/L, REPEAT = 105 G/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HGB RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT RUN ON HQ00637, REPEAT ON HQ00635 30APR2024 SAMPLE ID (B)(6) HGB INITIAL RESULT = 56.2 G/L, REPEAT = 112 G/L SAMPLE ID (B)(6) HGB INITIAL RESULT = 73.5 G/L, REPEAT = 114 G/L SAMPLE ID (B)(6) HGB INITIAL RESULT = 53.9 G/L, REPEAT = 105 G/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895901 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    920503 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SHEATH FILTER, FILTER VENTED 0.45UM, (B)(6)