BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 8362894 · Received February 22, 2019

    Report

    Report Number
    2919069-2019-00006
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Report Date
    August 25, 2019
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740002732
    PMA / PMN Number
    K991605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MEDICAL DEVICE REPORT WAS SUBMITTED WITH AN INCORRECT SUBMISSION NUMBER IN IND. THE PMA/510K WAS CHANGED FROM K980614 TO K991605. NO FURTHER UPDATES WERE NECESSARY.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT INFORMATION: NO PATIENTS INVOLVED.

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED BY REPLACING THE POWER SUPPLY. A REVIEW OF SERVICE TICKETS FOR THE CELL-DYN 3700 SL SERIAL (B)(4) DID NOT IDENTIFY ANY TICKETS RELATED TO THE ISSUE. REVIEW OF COMPLAINT AND TRENDING DATA FOR THE POWER SUPPLY DID NOT IDENTIFY ANY ISSUES OR TRENDS ASSOCIATED WITH THE CUSTOMER'S ISSUE. A REVIEW OF THE CELL-DYN 3700 SL TRACKING AND TRENDING DATA DID NOT IDENTIFY ANY ADVERSE TRENDS OR ABNORMAL COMPLAINT ACTIVITY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION AND THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE CELL-DYN 3700 SL ANALYZER WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER SYSTEM ACTIVATION, SMOKE WAS OBSERVED FROM THE CELL-DYN 3700 SL ANALYZER. THERE WAS NO REPORT OF INJURY OR ADVERSE IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156803 CELL-DYN 3700 SL ANALYZER AUTOMATED HEMATOLOGY ANALYZER, GKZ ABBOTT DIAGNOSTICS DIVISION 00380740002732

    Patients

    Seq Age Sex Outcome Treatment
    1