BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESTINY MAX

    MDR report key: 5044599 · Received September 1, 2015

    Report

    Report Number
    5044599
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    June 18, 2015
    Report Date
    August 11, 2015
    Manufacturer
    DIAGNOSTICA STAGO, INC
    Product Code
    JPA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TECHNOLOGIST WAS PERFORMING DAILY MAINTENANCE ON THE SPECIMEN SAMPLING PROBE OF THE DESTINY MAX COAGULATION ANALYZER. WHEN RAISING HER HAND TO MOVE IT OUT OF THE ANALYZER, HER RIGHT INDEX FINGER WAS PIERCED WITH THE SAMPLE PROBE. SHE STATED THAT SHE APPARENTLY DID NOT MOVE HER HAND TO THE FRONT OF THE PROBE BEFORE LIFTING IT UP AND OUT THE ANALYZER. THE SAFETY CONCERN IS THAT THERE ARE TWO SETS OF INSTRUCTIONS REGARDING THE PROCEDURE FOR CLEANING THE SAMPLING PROBE. ON-ANALYZER: STATES TO SOAK LINT FREE SWABS WITH REAGENT ALCOHOL TO WIPE OFF THE PROBE, CLEANING FROM TOP TO BOTTOM. THE MANUFACTURER TRAINER INSTRUCTIONS ARE TO CLEAN WITH AN ALCOHOL PAD AND THOROUGHLY RUB AROUND THE PROBE TO CLEAN OFF THE PLASMA/PROTEIN BUILD UP. SUPERVISORS HAVE VOICED THEIR CONCERN WITH THE MANUFACTURER WITHOUT AN ACCEPTABLE SOLUTION. THE LAB PREVIOUSLY REQUESTED A TEFLON COATED PROBE TO FACILITATE EASE OF CLEANING. THE MANUFACTURER RESPONDED THAT THIS WAS NOT POSSIBLE. AFTER LEARNING OF THIS EVENT, I SUGGESTED THAT THE LAB REQUEST A BLUNT SAMPLING PROBE BECAUSE THE CAP PIERCING FEATURE IS NOT USED IN OUR LAB (ALL CAPS ARE REMOVED BEFORE SPECIMENS ARE PLACED ON THE ANALYZER FOR TESTING). THE MANUFACTURER RESPONDED THAT THIS WAS ALSO NOT POSSIBLE. THERE IS ALSO A PLASTIC GUARD/SHIELD IN FRONT OF THE SECTION WHERE THE SAMPLE PROBE IS ACCESSED, MAKING IT NECESSARY FOR SOME EMPLOYEES TO LEAN OVER IN ORDER TO REACH THE PROBE TO CLEAN. THIS CAN BE DIFFICULT TO CLEAN THE PROBE FOR SOME DUE TO THE AWKWARD POSITION REQUIRED TO REACH THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577691 DESTINY MAX SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA DIAGNOSTICA STAGO, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R