BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 18465278 · Received January 8, 2024

    Report

    Report Number
    2919069-2024-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    December 15, 2023
    Report Date
    July 1, 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

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT. THE FSR FOUND HEAVY CRYSTALLIZATION AROUND HGB REAGENT SUPPLY VALVES (125 &126), AND REPLACED VALVES AND FITTINGS. THE HGB CRADLE 1 WAS ALSO NOTED TO BE CRYSTALIZED; HOWEVER, IT WAS NOT DETERMINED TO HAVE IMPACTED HGB RESULTS. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSED THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO DEFICIENCY 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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN (HGB) PATIENT RESULTS ON THE ALINITY HQ PROCESSING MODULE. THE SAMPLES RETESTED HIGHER ON A DIFFERENT MODULE. ONE EXAMPLE WAS PROVIDED. (B)(6)2023 FEMALE PATIENT WHO HAD ECTOPIC PREGNANCY ALINITY HQ HGB RESULT OF 73 G/L WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE WARD. REPEAT TESTING GENERATED A HGB RESULT OF 123 G/L. A NEW SAMPLE WAS DRAWN AND THE HGB RESULT WAS 128 G/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192753 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    567772 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female