BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 19296628 · Received May 13, 2024

    Report

    Report Number
    2919069-2024-00033
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 17, 2024
    Report Date
    August 14, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D2B PROCODE WAS UPDATED FROM GRZ TO GKZ. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. 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. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY HQ PROCESSING MODULE FOR SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: SID (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 DISCREPANT NEUTROPHIL (ABSOLUTE) RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID 00417210058 INITIAL RESULT = 0.152 10E3/UL; REPEATS = (B)(6) AND 1.29 10E3/UL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. PER Q-22-01-015, EDITION 009, FALSELY ELEVATED AND FALSELY DEPRESSED NEUTROPHIL (ABSOLUTE) RESULTS WITH A SHIFT >50% AND ONE VALUES IS < OR = TO 0.5 10E3/UL AND THE OTHER VALUE IS >0.5 10E3/UL IS REPORTABLE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT NEUTROPHIL (ABSOLUTE) RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6) INITIAL RESULT = 0.152 10E3/UL; REPEATS = 0.58310E3/UL AND 1.29 10E3/UL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. PER Q-22-01-015, EDITION 009, FALSELY ELEVATED AND FALSELY DEPRESSED NEUTROPHIL (ABSOLUTE) RESULTS WITH A SHIFT >50% AND ONE VALUES IS < OR = TO 0.5 10E3/UL AND THE OTHER VALUE IS >0.5 10E3/UL IS REPORTABLE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449318 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    592656 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown