BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS INTEGRA 800

    MDR report key: 2992165 · Received March 7, 2013

    Report

    Report Number
    1823260-2013-01369
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING AN ANALYZER ISSUE, THE CUSTOMER WAS INSTRUCTED BY THE TECHNICAL SUPPORT SPECIALIST TO UNPLUG CONNECTORS FROM A CIRCUIT BOARD. IN THE PROCESS OF UNPLUGGING THE TWO CONNECTORS, THE CUSTOMER RECEIVED TWO DEEP PUNCTURES IN HER RIGHT THUMB BY THE "PRONGS" ON THE CIRCUIT BOARD. A LAB INCIDENT REPORT WAS FILED AND THE CUSTOMER WENT TO THE ER. THE PUNCTURE WAS CLEANED WITH SOAP AND WATER AND WAS TREATED WITH "CHLORA- PREP" ANTISEPTIC. THE CUSTOMER WAS ALSO GIVEN A TETANUS SHOT. THE CUSTOMER WAS NOT INCAPACITATED IN ANY WAY AND WAS ABLE TO CONTINUE WORK. HER CONDITION WAS GIVEN AS "GOOD". THE CUSTOMER WAS WEARING A LAB COAT AND GLOVES, BUT NO SAFETY GLASSES. PRODUCT LABELING FOR PERFORMING THESE TROUBLESHOOTING STEPS STATES TO BEWARE OF SHARP METAL EDGES WHEN PERFORMING MAINTENANCE AND THAT FAILURE TO FOLLOW PRECAUTIONS MAY RESULT IN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96662 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR Required Intervention