BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA 2000 SYSTEM FOR HBA1C

    MDR report key: 1057274 · Received June 4, 2008

    Report

    Report Number
    1217157-2008-00006
    Event Type
    Other
    Date Received
    June 4, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 3, 2008
    Manufacturer
    BAYER CORP.
    Product Code
    LCP
    PMA / PMN Number
    K951361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS PROVIDED DETAILS OF EXCHANGE PROGRAM AND WILL ADVISE IF THEY REQUIRE FURTHER ASSISTANCE. RESULTS: THE CARTRIDGE WAS STUCK IN THE CARTRIDGE COMPARTMENT AND THE TAB WAS BROKEN IN THE ATTEMPT TO REMOVE THE CARTRIDGE. CONCLUSIONS: 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 SCREW DRIVER TO REMOVE THE CARTRIDGE AND IN AN ATTEMPT TO REMOVE THE STUCK HGBA1C CARTRIDGE, BROKE THE PLASTIC TAB OFF AND CUT HER FINGER. CUT WAS CLEANED AND NO FURTHER MEDICAL ATTENTION WAS SOUGHT.

    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