BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA DCA 2000

    MDR report key: 864219 · Received June 11, 2007

    Report

    Report Number
    2432235-2007-00018
    Event Type
    Other
    Date Received
    June 11, 2007
    Date of Event
    May 8, 2007
    Report Date
    May 9, 2007
    Manufacturer
    BAYER CORP.
    Product Code
    LCP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NARRATIVE: DISCUSSIONS BETWEEN A SIEMENS REP AND THE CUSTOMER INDICATED THAT SHE WAS USING THE PROPER TECHNIQUE TO REMOVE THE REAGENT CARTRIDGE BUT IT WAS STUCK IN THE INSTRUMENT. THE CARTRIDGE AND INSTRUMENT ARE BEING SENT BACK TO SIEMENS DIAGNOSTICS FOR FURTHER EVALUATION. THE REAGENT CARTRIDGE WAS DIFFICULT TO REMOVE FROM SYSTEM. THIS EVENT IS BEING REPORTED BECAUSE IT OCCURRED IN A POTENTIALLY BIOHAZARDOUS ENVIRONMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT IN 2007, A TECH CUT HER HAND WHILE TRYING TO REMOVE AN HBA1C REAGENT KIT FROM THE DCA TESTING COMPARTMENT AREA. THE INJURY, A MINOR CUT, WAS CLEANSED WITH PEROXIDE. NO STITCHES WERE NECESSARY. THE CUSTOMER CLAIMED THAT THE ISSUE WAS CAUSED BY DIFFICULTY IN REMOVING THE TEST CARTRIDGE FROM THE DCA. IN ORDER TO REMOVE THE CARTRIDGE FROM THE TESTING COMPARTMENT, THE CUSTOMER PUSHED DOWN ON THE GRAY TAB AND PUSHED RIGHT TO LIFT UP. AT THIS POINT THE PLASTIC TAB BROKE OFF OF THE CARTRIDGE CUTTING THE TECHNICIAN. THE CUSTOMER ALSO STATED THAT WHEN TRYING TO PULL OUT THE CARTRIDGE, THE AREA AROUND THE BLACK TESTING COMPARTMENT WAS "LOOSE". IT WAS ALSO REPORTED THAT THE CUSTOMER WAS NOT WEARING GLOVES WHEN PERFORMING THIS PROCEDURE. THE DCA 2000 OPERATING MANUAL RECOMMENDS THE USE OF GLOVES WHEN OPERATING THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA DCA 2000 DIABETES CARE SYSTEM LCP BAYER CORP. DCA 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other