BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN HEMOGLOBIN/NOC LYSE

    MDR report key: 2077058 · Received May 4, 2011

    Report

    Report Number
    2919069-2011-00191
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL REPORT WAS SUBMITTED UNDER CATALOG NUMBER 3H80-02, (B)(4) MANUFACTURING SITE. IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON CATALOG NUMBER 3H62-01, (B)(4) MANUFACTURING SITE. THE RISK MANAGEMENT FILE FOR THE CELLDYN 3700 ANALYZER INDICATES THAT THE USER MAY BE EXPOSED TO CHEMICAL HAZARDS WHEN COMING INTO CONTACT WITH REAGENTS DURING INSTRUMENT MAINTENANCE. CONTROLS IN PLACE TO REDUCE THE RISK ARE PERSONAL PROTECTIVE EQUIPMENT, HANDLING INSTRUCTIONS, HAZARD CLASSIFICATIONS, MATERIAL SAFETY DATA SHEETS, AND INSTRUCTIONS IN THE MANUAL FOR HANDLING AND MAINTENANCE OF THE INSTRUMENT. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE CELLDYN 3700 SYSTEM OPERATORS MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE LYSE REAGENT ON THE CD3700SL ANALYZER WAS EMPTY. WHEN SHE OPENED THE CAP OF THE LYSE REAGENT PART OF THE REAGENT THAT WAS LEFT IN THE BOTTLE SPRAYED OUT WITH PRESSURE IN HER EYE AND ON HER FACE. THE TECHNICIAN WASHED THE AREA WITH A LOT OF WATER. THERE WAS NO IRRITATION OR INJURY AND NO TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN HEMOGLOBIN/NOC LYSE LYSE REAGENT FOR HEMOGLOBIN ON THE CELL-DYN GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 CD3700 SL LN 2H31-01 SN (B)(4)| CD3700 SL LN 2H31-01 SN (B)(4)