BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 20602742 · Received November 4, 2024

    Report

    Report Number
    2919069-2024-00061
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 7, 2024
    Report Date
    December 30, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND DETERMINED THAT ALIGNMENT BETWEEN THE CUSTOMER'S ALINITY HQ MODULES CONTRIBUTED TO THE COMPLAINT ISSUE. THIS WAS ADDRESSED BY THE FSR WHICH RESOLVED THE ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE PRODUCT LIST NUMBER AND COMPLAINT ACTIVITY DID NOT IDENTIFY ANY TRENDS FOR THE ALINITY HQ INSTRUMENT WITH REGARDS TO THE CURRENT ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE, SERIAL NUMBER: (B)(6), WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: SIDS = (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 STATED FALSELY ELEVATED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ ANALYZER FOR A 78-YEAR-OLD FEMALE PATIENT WHO WAS TESTED AT ANOTHER HOSPITAL AND OBTAINED A LOWER RESULT. THE PHYSICIAN QUESTIONED THE ELEVATED RESULTS AS THE PATIENT HAS NOT HAD ANY TREATMENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024, SID: (B)(6), SEQ#: 852059, (B)(6) HGB = 8.52 G/DL, ON (B)(6) 2024, SID: (B)(6), SEQ#: 853963, (B)(6) HGB = 8.69 G/DL, ON (B)(6) 2024, HGB RESULT FROM ANOTHER HOSPITAL = 6.7 G/DL. PATIENT¿S PREVIOUS RESULTS: ON (B)(6) 2024, SID: (B)(6), SEQ#: 850427, (B)(6) HGB = 6.81 G/DL, ON (B)(6) 2024, SID: (B)(6), SEQ#: 850491, (B)(6) HGB = 6.93 G/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER STATED FALSELY ELEVATED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ ANALYZER FOR A 78-YEAR-OLD FEMALE PATIENT WHO WAS TESTED AT ANOTHER HOSPITAL AND OBTAINED A LOWER RESULT. THE PHYSICIAN QUESTIONED THE ELEVATED RESULTS AS THE PATIENT HAS NOT HAD ANY TREATMENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6)2024 SID (B)(6) SEQ#(B)(4) (HQ00754) HGB = 8.52 G/DL. (B)(6)2024 SID(B)(6) SEQ#(B)(4) (HQ00818) HGB = 8.69 G/DL. (B)(6)2024 HGB RESULT FROM ANOTHER HOSPITAL = 6.7 G/DL. PATIENT¿S PREVIOUS RESULTS: (B)(6)2024 SID (B)(6) SEQ#(B)(4) (HQ00754) HGB = 6.81 G/DL. (B)(6)2024 SID (B)(6) SEQ#(B)(4) (HQ00754) HGB = 6.93 G/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797042 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female