BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 6925739 · Received October 6, 2017

    Report

    Report Number
    2122870-2017-00051
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    August 24, 2017
    Report Date
    September 12, 2017
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590265373
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, WEIGHT, RACE AND ETHNICITY WERE NOT SUPPLIED. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S LABORATORY TO ASSESS INSTRUMENT PERFORMANCE. EVALUATION OF THE INSTRUMENT EVENT LOGS REMOTELY VIA PROSERVICE INDICATES THAT THE SYSTEM WAS NOT IN THE NOT READY STATE AT THE TIME OF THE EVENT AS INDICATED BY THE CUSTOMER AS THERE WERE NO ERRORS POSTED AND THE INSTRUMENT WAS CAPTURING TEMPERATURE AND PRESSURE DATA AS EXPECTED. IN CONCLUSION, THE CAUSE OF THE LABORATORY TECHNICIAN'S INJURY COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A LABORATORY TECHNICIAN HAD INJURED THEIR RIGHT HAND WHILE PERFORMING UNGUIDED TROUBLESHOOTING FOR AN INSTRUMENT ISSUE ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4). THE LABORATORY TECHNICIAN HAD OPENED THE FRONT PANELS AND REMOVED THE REAR ACCESS PANEL FROM THE INSTRUMENT TO DETERMINE THE SOURCE OF A NOISE. THE CUSTOMER NOTED THAT THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM WAS IN THE NOT READY STATE PRIOR TO REMOVING THE REAR ACCESS PANEL. THE LABORATORY TECHNICIAN HAD THEIR HAND IN THE INSTRUMENT WHEN AN UNKNOWN INTERNAL DEVICE MOVED AND STRUCK THEIR RIGHT WRIST. AN IMMEDIATE INJURY WAS NOT APPARENT HOWEVER THE LABORATORY TECHNICIAN REPORTED SWELLING AND BRUISING OF THEIR RIGHT WRIST APPROXIMATELY ONE (1) WEEK LATER ((B)(6) 2017). THE LABORATORY TECHNICIAN SOUGHT OUT MEDICAL CARE AT THIS TIME AND WAS DIAGNOSED WITH A HEMATOMA CONTUSION OF THE RIGHT WRIST. X-RAY INVESTIGATION DID NOT LOCATE A FRACTURE AND THERE WAS NO LACERATION OF THE SKIN. THE LABORATORY TECHNICIAN'S RIGHT WRIST WAS PLACED IN A STABILIZING SPLINT AND WRAPPED WITH AN ELASTIC BANDAGE. ADDITIONALLY, THE LABORATORY TECHNICIAN WAS PRESCRIBED IBUPROFEN AND TRAMADOL FOR PAIN RELIEF AND PLACED ON WORK RESTRICTIONS TO NOT USE THEIR RIGHT HAND. THE DAY FOLLOWING THE EVENT ((B)(6) 2017) IT WAS DISCOVERED THAT THE INTERLOCK BYPASS SWITCHES ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM HAD BEEN DEFEATED WITH REACTION VESSELS (RVS). THE INTERLOCK SWITCHES ARE A SAFETY FEATURE THAT REMOVES POWER FROM THE INSTRUMENT WHEN ONE OF THE FRONT PANELS IS OPENED WHICH THEN CAUSES THE INSTRUMENT TO ENTER THE NOT READY STATE. TO DATE IT IS UNKNOWN WHO PLACED THE RVS IN THE INTERLOCK BYPASS SWITCHES. ALTHOUGH THE INTERLOCK BYPASS SWITCHES WERE DEFEATED THE SYSTEM WAS IN THE NOT READY STATE DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699774 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA 15099590265373

    Patients

    Seq Age Sex Outcome Treatment
    1 Other