BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCA 2000

    MDR report key: 778209 · Received November 1, 2006

    Report

    Report Number
    2432235-2006-00013
    Event Type
    Other
    Date Received
    November 1, 2006
    Date of Event
    October 2, 2006
    Report Date
    November 1, 2006
    Manufacturer
    BAYER HEALTHCARE
    Product Code
    LCP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED BECAUSE (AS STATED IN OUR BIOHAZARD CAUTION STATEMENT) NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN BLOOD WILL NOT TRANSMIT INFECTIOUS AGENTS. A DEVICE MALFUNCTION DID NOT OCCUR. THE DEVICE OPERATED AND PERFORMED ACCORDING TO SPECS. THE INCIDENT WAS A USER ACCIDENT. PRODUCT LABELING REQUIRES ADHERING TO SAFETY PRECAUTIONS WHEN HANDLING THIS MATERIAL. FOR MEDICAL DEVICE REPORTING PURPOSES THIS IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    A CUSTOMER'S OFFICE RN STATED THAT WHILE SAMPLING THE DCA 2000 HEMOGLOBIN A1C NORMAL CONTROL MATERIAL USING AN EYE DROPPER, SHE ACCIDENTALLY SPLASHED SOME CONTROL MATERIAL INTO 1 OF HER EYES. SHE STATES THAT AT THE TIME OF THE INCIDENT, SHE WAS NOT WEARING PERSONAL PROTECTIVE EYEWEAR. SHE IMMEDIATELY FLUSHED HER EYES AT AN EYEWASH STATION FOR (15) MINS. SHE STATED THAT THERE WAS A BUBBLE IN THE EYE DROPPER THAT POPPED AND CAUSED SMALL AMOUNT OF THE CONTROL MATERIAL TO SPLASH. SINCE HUMAN SOURCED MATERIAL LAWS WAS USED IN THE MFG OF THE PRODUCT, THE INCIDENT WAS HANDLED AS A POTENTIAL BIOHAZARD. EVENTS SUCH AS THIS ARE COVERED BY THE PRODUCT LABELING. THE INSTRUCTIONS FOR USE CLEARLY STATE THE FOLLOWING WARNINGS AND PRECAUTIONS STATEMENT: CAUTION: BECAUSE NO TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT HIV, HEPATITIS B OR C VIRUSES, OR OTHER INFECTIOUS AGENTS ARE ABSENT, THESE PRODUCTS SHOULD BE HANDLED AT THE BIOSAFETY LEVEL II AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN BLOOD SPECIMEN IN PROTECTION OF LABORATORY WORKERS FROM INFECTIOUS DISEASE TRANSMITTED BY BLOOD, BODY FLUIDS, AND TISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCA 2000 HBA1C CONTROL (GLYCOSYLATED HEMOGLOBIN ASSAY) LCP BAYER HEALTHCARE 5031C *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other