BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA 2000 SYSTEM FOR HBA1C

    MDR report key: 1055442 · Received May 21, 2008

    Report

    Report Number
    1217157-2008-00004
    Event Type
    Other
    Date Received
    May 21, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BAYER CORP.
    Product Code
    LCP
    PMA / PMN Number
    K951361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE AND THE INSTRUMENT ARE BEING SENT BACK TO SIEMENS HEALTHCARE FOR FURTHER EVALUATION. RESULTS: THE CARTRIDGE WAS STUCK IN THE CARTRIDGE COMPARTMENT AND THE TAB WAS BROKEN. CONCLUSION: THE CUSTOMER, WHEN TRYING TO REMOVE THE STUCK HGBA1C CARTRIDGE FROM THE UNIT, BROKE THE PLASTIC TAB OFF AND CUT HER FINGER. THIS EVENT IS BEING REPORTED BECAUSE IT OCCURRED IN A POTENTIALLY BIOHAZARDOUS ENVIRONMENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A CARTRIDGE WAS STUCK IN THE INSTRUMENT. THE CUSTOMER USED A FLAT HEAD SCREW DRIVER AND A PAIR OF TWEEZERS TO REMOVE THE CARTRIDGE. THE CUSTOMER, IN AN ATTEMPT TO REMOVE THE STUCK HGBA1C CARTRIDGE, BROKE THE PLASTIC TAB OFF AND CUT HER FINGER. THE CARTRIDGE AND THE INSTRUMENT ARE BEING SENT BACK TO SIEMENS HEALTHCARE FOR FURTHER EVALUATION. THE CUSTOMER SOUGHT MEDICAL ATTENTION FROM THE DOCTOR IN THE FACILITY WHO, WAS ABLE TO CLEAN THE CUT AND BANDAGE THE WOUND. IT WAS FURTHER REPORTED THAT THE CUT WAS NOT SEVERE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA