BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY HQ PROCESSING MODULE

    MDR report key: 19408956 · Received May 28, 2024

    Report

    Report Number
    2919069-2024-00037
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    May 13, 2024
    Report Date
    July 24, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GKZ
    UDI-DI
    00380740138851
    PMA / PMN Number
    K220031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW SECTION G3 - DATE RECEIVED BY MFG INADVERTENTLY HAD THE INCORRECT DATE OF 7/8/2028, THE CORRECT DATE WAS 7/8/2024.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION FOR SECTION D2B - PROCODE GRZ CHANGED TO GKZ THE FIELD SERVICE ENGINEER (FSE) SUSTAINED A DEEP CUT TO THE INDEX/FOREFINGER FROM THE INSTRUMENT'S EDGE (CHASSIS) WHILE REPLACING THE SIDE COVER ON AN ALINITY HQ PROCESSING MODULE. A BANDAGE WAS APPLIED TO THE CUT, AND THE FSE WAS GIVEN A TETANUS SHOT. NO ADDITIONAL INJURY OR TREATMENT WAS REPORTED AFTER THE INITIAL TREATMENT IN THIS INCIDENT. INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF THE SERIAL NUMBER HISTORY FOR (B)(6) DID NOT IDENTIFY OTHER INCIDENTS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE ALINITY HQ PROCESSING MODULE AND FRONT COVER KIT HQ DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE FOR SERIAL (B)(6) OR FRONT COVER KIT HQ WAS IDENTIFIED.

    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.

    Description of Event or Problem · 0

    THE FIELD SERVICE ENGINEER (FSE) REPORTED A CUT WHILE PERFORMING TECHNICAL SERVICE ON AN ALINITY HQ PROCESSING MODULE. THE FSE STATED THEY SUSTAINED A DEEP CUT ON THE EDGE OF THE ANALYZER WHILE REPLACING THE SIDE COVER. A BANDAGE WAS APPLIED TO THE CUT AND THE FSE WAS GIVEN A TETANUS SHOT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THERE WAS NO ADDITIONAL IMPACT TO THE USER.

    Description of Event or Problem · 0

    THE FIELD SERVICE ENGINEER (FSE) REPORTED A CUT WHILE PERFORMING TECHNICAL SERVICE ON AN ALINITY HQ PROCESSING MODULE. THE FSE STATED THEY SUSTAINED A DEEP CUT ON THE EDGE OF THE ANALYZER WHILE REPLACING THE SIDE COVER. A BANDAGE WAS APPLIED TO THE CUT AND THE FSE WAS GIVEN A TETANUS SHOT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THERE WAS NO ADDITIONAL IMPACT TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145109 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851
    311718 ALINITY HQ PROCESSING MODULE COUNTER, DIFFERENTIAL CELL GKZ ABBOTT LABORATORIES 00380740138851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention