BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 8982180 · Received September 10, 2019

    Report

    Report Number
    2919069-2019-00102
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 20, 2019
    Report Date
    February 27, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740017170
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) OBSERVED THE CELL-DYN RUBY POWER SUPPLY WAS DAMAGED AND BURNING. SMOKE DAMAGE WAS LIMITED TO THE POWER SUPPLY AND WAS THE ONLY PART DAMAGED, NO OTHER COMPONENTS WERE AFFECTED. REPLACING THE POWER SUPPLY RESOLVED THE ISSUE. DUE TO THE DAMAGE OBSERVED IN THE POWER SUPPLY, IT COULD NOT BE DETERMINED WHERE THE TRACK DAMAGE STARTED IN THE PART. A REVIEW OF THE SERVICE HISTORY FOR THE CELL-DYN RUBY REVEALED NO ADDITIONAL ISSUES WERE REPORTED POST REPLACING OF THE POWER SUPPLY. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE CELL-DYN RUBY. LABELING WAS REVIEWED AND CONTAINS ADEQUATE INFORMATION ON HAZARD, SAFETY, HOW TO MINIMIZE POTENTIAL HARM TO PERSONNEL, AND PRECAUTIONS, SUCH AS WEARING PERSONAL PROTECTIVE EQUIPMENT. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN RUBY, SN (B)(4).

    Additional Manufacturer Narrative · 1

    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 · 1

    THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THE POWER SUPPLY WAS BURNING UPON A CELL-DYN RUBY INSTALLATION. SMOKE DAMAGE WAS LIMITED TO THE POWER SUPPLY. NO REPORTED IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778468 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 08H67-01 00380740017170

    Patients

    Seq Age Sex Outcome Treatment
    1