BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA 2000 & 2000+ SYSTEM FOR HBA1C

    MDR report key: 1242565 · Received November 21, 2008

    Report

    Report Number
    1217157-2008-00014
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BAYER CORP.
    Product Code
    LCP
    PMA / PMN Number
    K951361
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED BECAUSE IT OCCURRED IN A POTENTIALLY BIOHAZARDOUS ENVIRONMENT.

    Description of Event or Problem · 1

    A TECHNICIAN CUT HIMSELF WHILE USING FORCEPS TO REMOVE A STUCK CARTRIDGE. THE CUT, WHICH WAS MINOR, WAS CLEANED WITH NEOSPORIN AND BANDAGED. NO FURTHER MEDICAL TREATMENT WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCA 2000 & 2000+ SYSTEM FOR HBA1C DCA 2000 & 2000+ SYSTEM FOR HBA1C LCP BAYER CORP. 5031C

    Patients

    Seq Age Sex Outcome Treatment
    1