BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA 2000

    MDR report key: 916489 · Received September 18, 2007

    Report

    Report Number
    2432235-2007-00033
    Event Type
    Other
    Date Received
    September 18, 2007
    Date of Event
    August 15, 2007
    Report Date
    August 15, 2007
    Manufacturer
    BAYER CORP.
    Product Code
    LCP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NARRATIVE: THE CARTRIDGE AND INSTRUMENT ARE BEING SENT BACK TO SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS FOR FURTHER EVALUATION. EVALUATION: THE REAGENT CARTRIDGE WAS DIFFICULT TO REMOVE FROM THE SYSTEM. THIS EVENT IS BEING REPORTED BECAUSE IT OCCURRED IN A POTENTIALLY BIOHAZARDOUS ENVIRONMENT.

    Description of Event or Problem · 1

    IN 2007, A CUSTOMER CUT HER HAND WHILE TRYING TO REMOVE AN HBA1C REAGENT CARTRIDGE FROM THE DCA TESTING COMPARTMENT AREA. THE CUSTOMER CLAIMED THAT SHE WAS UNABLE TO REMOVE THE CARTRIDGE FROM THE DCA AFTER USING TWEEZERS AND PRESSING THE RELEASE BUTTON. THE CUSTOMER CUT A FINGER WHEN THE TAB ON THE CARTRIDGE SNAPPED OFF. THE CUT WAS EVALUATED BY A NURSE PRACTITIONER WHO RINSED AND BANDAGED THE FINGER AND DETERMINED THAT STITCHES WERE NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCA 2000 DIABETES CARE SYSTEM LCP BAYER CORP. DCA 2000+ LOT#0611067

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other