BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM - REFURBISHED

    MDR report key: 8101549 · Received November 26, 2018

    Report

    Report Number
    1319681-2018-00118
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    October 29, 2018
    Report Date
    November 26, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT AN OPERATOR SUSTAINED A CUT FINGER WHEN MANIPULATING THE MICROSLIDE INCUBATOR RING ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE MOST LIKELY CAUSE OF THE EVENT WAS USER ERROR, AS AN OPERATOR SUSTAINED THE CUT WHEN ATTEMPTING TO CLEAR A SLIDE CARTRIDGE JAM ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE OPERATOR SUSTAINED A CUT AS A RESULT OF THIS EVENT, IMMEDIATELY WASHED THEIR HAND AND CLEANED THE CUT WITH ALCOHOL BEFORE APPLYING A BANDAGE. THE OPERATOR WENT TO THE INTERNAL HEALTH CLINIC WHERE GLUE WAS APPLIED TO THE CUT. THE OPERATOR STATED THAT THEY WERE WEARING GLOVES AT THE TIME OF THE EVENT. THERE WAS NO EVIDENCE TO SUGGEST THAT THE VITROS 5,1 FS CHEMISTRY SYSTEM MALFUNCTIONED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN OPERATOR SUSTAINED A CUT FINGER WHEN MANIPULATING THE MICROSLIDE INCUBATOR RING ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THERE WAS NO ALLEGATION OF SERIOUS OR LONG TERM PERMANENT INJURY AND NO LONG TERM CONSEQUENCES ARE EXPECTED. HOWEVER, THERE IS A POTENTIAL THAT THE OPERATOR MIGHT BE EXPOSED TO BLOOD BORNE PATHOGENS AND SHOULD BE CONSIDERED AS A SERIOUS INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO).COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941972 VITROS 5,1 FS CHEMISTRY SYSTEM - REFURBISHED CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1