BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 18712246 · Received February 15, 2024

    Report

    Report Number
    2919069-2024-00017
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    February 7, 2024
    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
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE REPLACED OF VALVE-CHECK, INLINE, PPRO (LIST NUMBER (B)(6) WHICH RESOLVED THE ISSUE. REVIEW OF THE DATA FOUND THAT THE NEU, LYM, MONO, EOS, AND IG PARAMETERS WERE FLAGGED AS INVALID AND BOUNDARY NOT FOUND FLAGS WERE GENERATED FOR SEQ 305359. THE REVIEW DID NOT IDENTIFY ANY ADVERSE TRENDS OR ABNORMAL COMPLAINT ACTIVITY. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSED THE ISSUE UNDER REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE PRODUCT HISTORICAL DATA DID NOT FIND A PRODUCT ISSUE RELATED TO THE COMPLAINT INCIDENT. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE, LIST NUMBER 09P68, SERIAL NUMBER (B)(6) 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. UPDATED INFORMATION IN SECTION D4 PRIMARY UDI NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED CBC (COMPLETE BLOOD COUNT) RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL RESULTS FROM ALINITY HQ00417 /REPEATED ON ALINITY HQ00416WBC INITIAL=2.41 /REPEATED=5.65; RBC INITIAL=3.06 /REPEATED=5.38; HEMOGLOBIN INITIAL=7.92 G/DL /REPEATED=15.3 G/DL; PLATELET INITIAL=178 /REPEATED=269 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED CBC (COMPLETE BLOOD COUNT) RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL RESULTS FROM ALINITY HQ00417 /REPEATED ON ALINITY HQ00416 WBC INITIAL=2.41 /REPEATED=5.65; RBC INITIAL=3.06 /REPEATED=5.38; HEMOGLOBIN INITIAL=7.92 G/DL /REPEATED=15.3 G/DL; PLATELET INITIAL=178 /REPEATED=269 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086756 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    435400 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown