BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPLEX 2200

    MDR report key: 7113356 · Received December 13, 2017

    Report

    Report Number
    1000135116-2017-00001
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    September 12, 2017
    Report Date
    December 12, 2017
    Manufacturer
    BIO-RAD LABORATORIES, INC
    Product Code
    NSU
    UDI-DI
    00847865002813
    PMA / PMN Number
    BK140112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY MANAGER CALLED ON (B)(6), 2017 TO INFORM THAT A TECHNICIAN WAS INJURED (CUT) WHILE REMOVING A STUCK SAMPLE TRAY. THEY ARE CONCERNED BECAUSE THEY WERE RUNNING (B)(6) SAMPLES DURING THE INCIDENT. BIO-RAD TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE INJURED TECHNICIAN AND GATHERED SOME INFORMATION REGARDING THE INCIDENT. THE TECHNICIAN INFORMED THAT THE INCIDENT HAPPENED ON (B)(6) 2017. HE WAS RUNNING (B)(6) SAMPLES WHEN HE RECEIVED AN ERROR. HE CAN'T REMEMBER WHAT THE ERROR WAS BUT HE NOTICED THE SAMPLE TRAY WAS STUCK. HE REMOVED THE FRONT COVER OF THE BIOPLEX AND TRIED TO GET THE RACK OUT WITH SOME FORCE AND THAT IS WHEN HE CUT HIS HAND. HE WAS WEARING LAB COAT, GLOVES AND EYE SHIELD. HE IMMEDIATELY RINSED HIS HAND WITH SOAP WATER, WIPED WITH ALCOHOL SWAB AND APPLIED BANDAGE. HE WENT TO SEEK TREATMENT THE NEXT DAY ON (B)(6) 2017. HE WAS TESTED FOR (B)(6) AND THE RESULT WAS NEGATIVE. HE WAS ALSO GIVEN PROPHYLAXIS TREATMENT OF ISENTRESS 400MG TWICE DAILY AND TRUVADA 200MG DAILY FOR 30 DAYS. HE WAS RETESTED FOR (B)(6) IN OCTOBER AND THE RESULT WAS NEGATIVE. CUSTOMER WAS ADVISED NOT TO REMOVE STUCK TRAYS WITH FORCE. HE WAS DIRECTED TO THE USER MANUAL AND WAS GIVEN INSTRUCTION TO SAFELY REMOVE THE TRAY USING THE MAINTENANCE USER INTERFACE.

    Description of Event or Problem · 1

    RECEIVED A CALL ON (B)(6) 2017. TECHNICIAN REPORTED THAT WHILE HE WAS RUNNING A SAMPLE ON SEPTEMBER (B)(6) 2017, HE RECEIVED AN ERROR MESSAGE. THE SAMPLE RACK WAS STUCK. HE REMOVED THE FRONT COVER TO TRY TO GET THE RACK OUT WITH SOME FORCE AND THAT IS WHEN HE CUT HIS HAND. HE WAS RUNNING HIV TEST ON THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895153 BIOPLEX 2200 BIOPLEX 2200 SYSTEM NSU BIO-RAD LABORATORIES, INC BIOPLEX 2200 N/A 00847865002813

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other