BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 17884651 · Received October 6, 2023

    Report

    Report Number
    2919069-2023-00034
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 19, 2023
    Report Date
    June 28, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND REPLACED VARIOUS TUBING FOR THE WASTE TANK AND WASTE SUBSYSTEM AND VALVES V92 AND V94 WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY HQ PROCESSING MODULE 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) WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS BEING SUBMITTED TO CORRECT A TYPOGRAPHICAL ERROR IN SECTION D2B. THE INCORRECT CODE OF GRZ WAS CORRECTED TO GKZ. ADDITIONAL INFORMATION PROVIDED IN SECTION D4 PRIMARY UDI NUMBER: (B)(6). THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND REPLACED VARIOUS TUBING FOR THE WASTE TANK AND WASTE SUBSYSTEM AND VALVES V92 AND V94 WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY HQ PROCESSING MODULE 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) WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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 DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ ANALYZER FOR TWO PATIENTS. THE HEMOGLOBIN RESULTS WERE NOT CONSISTENT WITH THE PATIENTS¿ HISTORICAL RESULTS. THE SAME SAMPLES WERE REPEATED ON ANOTHER ALINITY HQ ANALYZER AND THE RESULTS MATCHED UP WITH THE PATIENTS¿ HISTORICAL RESULTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: SAMPLE NUMBER (B)(6). INITIAL HEMOGLOBIN RESULT = 60.0 G/L. REPEAT HEMOGLOBIN RESULT ON THE SAME ANALYZER = 127.0 G/L. REPEAT HEMOGLOBIN RESULT ON ANOTHER ALINITY HQ (HQ00903) = 125.0 G/L. PATIENT 2: SAMPLE NUMBER (B)(6). INITIAL HEMOGLOBIN RESULT = 76.3 G/L. REPEAT HEMOGLOBIN RESULT ON ANOTHER ALINITY HQ (HQ00903) = 153.0 G/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ ANALYZER FOR TWO PATIENTS. THE HEMOGLOBIN RESULTS WERE NOT CONSISTENT WITH THE PATIENTS¿ HISTORICAL RESULTS. THE SAME SAMPLES WERE REPEATED ON ANOTHER ALINITY HQ ANALYZER AND THE RESULTS MATCHED UP WITH THE PATIENTS¿ HISTORICAL RESULTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: SAMPLE NUMBER (B)(6), INITIAL HEMOGLOBIN RESULT = 60.0 G/L, REPEAT HEMOGLOBIN RESULT ON THE SAME ANALYZER = 127.0 G/L, REPEAT HEMOGLOBIN RESULT ON ANOTHER ALINITY HQ ((B)(6)) = 125.0 G/L. PATIENT 2: SAMPLE NUMBER (B)(6), INITIAL HEMOGLOBIN RESULT = 76.3 G/L, REPEAT HEMOGLOBIN RESULT ON ANOTHER ALINITY HQ ((B)(6)) = 153.0 G/L, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ ANALYZER FOR TWO PATIENTS. THE HEMOGLOBIN RESULTS WERE NOT CONSISTENT WITH THE PATIENTS¿ HISTORICAL RESULTS. THE SAME SAMPLES WERE REPEATED ON ANOTHER ALINITY HQ ANALYZER AND THE RESULTS MATCHED UP WITH THE PATIENTS¿ HISTORICAL RESULTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1: SAMPLE NUMBER (B)(6). INITIAL HEMOGLOBIN RESULT = 60.0 G/L. REPEAT HEMOGLOBIN RESULT ON THE SAME ANALYZER = 127.0 G/L. REPEAT HEMOGLOBIN RESULT ON ANOTHER ALINITY HQ (HQ00903) = 125.0 G/L. PATIENT 2: SAMPLE NUMBER (B)(6). INITIAL HEMOGLOBIN RESULT = 76.3 G/L. REPEAT HEMOGLOBIN RESULT ON ANOTHER ALINITY HQ (HQ00903) = 153.0 G/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225459 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    878253 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown