BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN 3500 SL ANALYZER

    MDR report key: 4960416 · Received August 3, 2015

    Report

    Report Number
    2919069-2015-00044
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K955715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICAL SUPPORT EMPLOYEE STATED THAT THE CELL-DYN 3500 INVOLVED IS A NON-ACTIVE DEMONSTRATION OBJECT THAT WAS COMPLETELY TAKEN OUT OF SERVICE AND ONLY BEING USED AS A DEMONSTRATION TOOL. THE CELL-DYN 3500 ANALYZER WAS RETIRED BY ABBOTT LABORATORIES ON JUNE 30, 2012. THE TECHNICAL SUPPORT EMPLOYEE WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE INCIDENT. PRODUCT LABELING WAS REVIEWED. STEP BY STEP INSTRUCTIONS ON HOW TO REPLACE SAMPLE LOADER VENT/ASPIRATION NEEDLE ARE INCLUDED IN THE OPERATOR'S MANUAL. THE INSTRUCTIONS CLEARLY STATE TO USE NEEDLE NOSE PLIERS, GRIP THE HOLDING CLIP ON THE MOUNTING BLOCK AND CAREFULLY PULL IT FORWARD UNTIL IT CLEARS THE BLOCK. IN ADDITION, THE MANUAL STATES TO WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT. THE TECHNICAL SUPPORT EMPLOYEE DID NOT REFER TO THE CELL-DYN 3700 OPERATOR'S MANUAL. INSTEAD, SHE USED A RETIRED CELL-DYN 3500 INSTRUMENT, USED HER FINGERS AS OPPOSED TO PLIERS, AND SHE WAS NOT WEARING PPE. BASED ON RESULTS OF THIS INVESTIGATION, THE INCIDENT WAS DETERMINED TO BE DUE TO USE ERROR. NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE CELL-DYN 3500 IS RETIRED AND SHOULD NOT HAVE BEEN USED FOR TROUBLESHOOTING THE CELL-DYN 3700. THE CELL-DYN 3700 OPERATOR'S MANUAL CONTAINS ADEQUATE INSTRUCTIONS FOR THE TROUBLESHOOTING PERFORMED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    AN ABBOTT TECHNICAL SUPPORT EMPLOYEE THAT WAS TROUBLESHOOTING A CELL-DYN 3700 ANALYZER STATED THAT WHILE ATTEMPTING TO REMOVE THE CLOSED MODE PROBE OFF AN INACTIVE CELL-DYN 3500 ANALYZER, SHE INJURED HER LEFT THUMB ON THE CORNER OF THE METAL CLIP THAT HOLDS THE PROBE. SHE DIDN'T NOTICE THE INJURY AT FIRST, BECAUSE IT WAS SMALL, UNTIL IT STARTED TO BLEED. THERE WAS NO DIRECT CONTACT WITH THE PROBE ITSELF. A BOOSTRIX VACCINE (TETANUS, DIPHTHERIA, AND PERTUSSIS) WAS GIVEN BY THE COMPANY DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504519 CELL-DYN 3500 SL ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LIST NUMBER 9311498, LOT NUMBER UNKNOWN