BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 17905453 · Received October 10, 2023

    Report

    Report Number
    2919069-2023-00035
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 18, 2023
    Report Date
    June 27, 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

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND PERFORMED MANUAL BENCH CLEANING, MANUAL CLEANING OF THE HGB FLOW CELL, AND CLEANING OF THE HGB CUPS. ADDITIONALLY, THE LUER FITTING WAS TIGHTENED AND VALVE V09 WAS REPLACED. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING OF THE ALINITY HQ DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY HQ PROCESSING MODULE FOR SERIAL NUMBER HQ00570 WAS IDENTIFIED.SECTION G1 HAS BEEN UPDATED TO CURRENT CONTACT INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION WAS MADE TO FIELD D2B PRO CODE. THE INCORRECT CODE OF GRZ WAS CHANGED TO CORRECT CODE GKZ. THIS WAS A TYPOGRAPHICAL ERROR CORRECTION. UPDATED INFORMATION IN SECTION D4 PRIMARY UDI NUMBER.

    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 DECREASED HEMOGLOBIN RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE WHICH DOES NOT MATCH WITH ANOTHER ALINITY HQ PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: PATIENT 1: INITIAL= 69 G/L /REPEATED= 127 G/L. PATIENT 4: INITIAL= 64 G/L /REPEATED= 111 G/L. PATIENT 5: INITIAL= 75 G/L /REPEATED= 155 G/L. THERE WAS NO TREATMENT OR TRANSFUSION PROVIDED TO PATIENTS DUE TO FALSELY DECREASED HEMOGLOBIN RESULTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE WHICH DOES NOT MATCH WITH ANOTHER ALINITY HQ PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: PATIENT 1: INITIAL= 69 G/L /REPEATED= 127 G/L. PATIENT 4: INITIAL= 64 G/L /REPEATED= 111 G/L. PATIENT 5: INITIAL= 75 G/L /REPEATED= 155 G/L. THERE WAS NO TREATMENT OR TRANSFUSION PROVIDED TO PATIENTS DUE TO FALSELY DECREASED HEMOGLOBIN RESULTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227410 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    296069 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown