BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCELERATOR A3600

    MDR report key: 6391188 · Received March 9, 2017

    Report

    Report Number
    3010825766-2017-00002
    Event Type
    Injury
    Date Received
    March 9, 2017
    Date of Event
    January 13, 2017
    Report Date
    March 9, 2017
    Manufacturer
    INPECO SA
    Product Code
    JQP
    PMA / PMN Number
    K121012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 A LAB TECHNICIAN INJURED FINGER WITH THE HANDLE OF A 12-SAMPLE TUBES RACK. THE TECHNICIAN WAS LOADING THE RACK ON THE ACCELERATOR A3600 AUTOMATION SYSTEM, SPECIFICALLY INTO THE INPUT/OUTPUT MODULE (IOM). ON (B)(6) 2017 INPECO BECAME AWARE THAT THE INJURED TECHNICIAN WENT TO ER AND BLOOD WAS DRAWN FOR TESTING A BASELINE FOR HIV/HEPS. A SECOND DRAW IS FORESEEN AT 3 MONTHS, THEN AGAIN AT 6 MONTHS. AT PRESENT, INVESTIGATION IS STILL ONGOING. THE EVENT ROOT CAUSE HAS NOT BEEN IDENTIFIED YET.

    Description of Event or Problem · 1

    THE ACCELERATOR A3600 PRODUCT DISTRIBUTOR WAS INFORMED THAT A TECH HAD INJURED FINGER ON (B)(6) 2017 WHILE PUSHING IN STAT CARRIER RACK AT IOM. SITE REPORTED THAT METAL HANDLE OF RACK CUT THROUGH TECH'S GLOVE AND CUT FINGER; RACK WAS PUSHED ALL THE WAY IN BUT FORCE OF PUSH FROM TECH RESULTED IN METAL HANDLE OF RACK BREAKING THROUGH GLOVE AND INTO SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173405 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM JQP INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other