BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 54151 · Received December 5, 1996

    Report

    Report Number
    1628664-1996-00023
    Event Type
    Other
    Date Received
    December 5, 1996
    Date of Event
    November 5, 1996
    Report Date
    December 4, 1996
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT APPROX MIDNIGHT A WORKER IN THE FACILITY WAS PERFORMING MAINTENANCE ON THE ANALYZER WHEN SPARKS WERE NOTED COMING FROM THE POWER CORD. WHILE ATTEMPTING TO UNPLUG THE ANALYZER FROM THE WALL OUTLET SHE WAS CUT AND BURNED ON HER FINGERS AND SPARKS WENT INTO HER FACE. SHE WAS TAKEN TO THE EMERGENCY ROOM WHERE HER HEART WAS MONITORED TO DETERMINE IF SHE WAS SHOCKED. BLOOD WORK WAS ORDERED AND SHE WAS SENT HOME FROM WORK. ADD'L INFO INDICATES THE OPERATOR DID NOT HAVE FACIAL BURNS OR EYE DAMAGE, ALTHOUGH HER CONTACT LENS WAS CRACKED IN THE INCIDENT. THE ACCOUNT COULD NOT PROVIDE WHAT INTERVENTION WAS GIVEN FOR THE FINGER CUT AND BURN. THE OPERATOR STILL SUFFERS FROM AN OCCASIONAL HEADACHE SINCE THE INCIDENT. BLOOD WORK THAT WAS ORDERED AND RESULTS ARE NOT AVAILABLE. THE ACCOUNT STATES THE ANALYZER WAS RELOCATED NOV 1ST BY MOVERS TO A NEW LOCATION. THE OPERATOR INJURED RETURNED TO WORK ON 11/13/96. A LAB TECHNICIAN STATED THAT A WIRE WAS COMING OUT OF THE PLUG BY THE THREE PRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMX ANALYZER AUTOMATED IMMUNOASSAY ANALYZER LCI ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other