BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 18361097 · Received December 19, 2023

    Report

    Report Number
    2919069-2023-00052
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 30, 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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION WAS MADE TO SECTION D2B PROCODE. THE INCORRECT CODE OF GRZ WAS CHANGED TO GKZ. THIS WAS A TYPOGRAPHICAL ERROR CORRECTION AND THERE IS NO FURTHER IMPACT TO THE SUBMISSION. ADDITIONAL INFORMATION PROVIDED IN SECTION D4 PRIMARY UDI NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR A FALSELY ELEVATED WHITE BLOOD CELLS (WBC) RESULTS, ON THE ALINITY HQ ANALYZER, SERIAL NUMBER (B)(6), INCLUDED A REVIEW OF COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. REVIEW OF THE SCATTERS INDICATED THAT THE WBCS ARE CLEARLY SEPARATED. NO INSTRUMENT PERFORMANCE ISSUE WAS IDENTIFIED. QC RECOVERED WITHIN RANGE. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = SAMPLE ID (B)(6) AND SAMPLE ID (B)(6) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED WHITE BLOOD CELL (WBC) COUNT RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT WAS 63.7, REPEAT WAS 27.5 10E3/UL. THE PATIENT WAS REDRAWN, UNDER SAMPLE ID (B)(6), AND THE RESULT WAS 30.0 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED WHITE BLOOD CELL (WBC) COUNT RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT WAS 63.7, REPEAT WAS 27.5 10E3/UL. THE PATIENT WAS REDRAWN, UNDER SAMPLE ID (B)(6) , AND THE RESULT WAS 30.0 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED WHITE BLOOD CELL (WBC) COUNT RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT WAS 63.7, REPEAT WAS 27.5 10E3/UL. THE PATIENT WAS REDRAWN, UNDER SAMPLE ID (B)(6), AND THE RESULT WAS 30.0 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892102 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    2206066 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown