BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 2858750 · Received December 5, 2012

    Report

    Report Number
    2919069-2012-00078
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED BREATHING ISSUES AFTER EXPOSURE TO FUMES DUE TO TONER SPILLAGE DURING REPLACEMENT FROM THE OKI B4600 PRINTER, WHICH WAS BEING USED WITH A CELL-DYN 1800 INSTRUMENT. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. CUSTOMER SERVICE AND SUPPORT SUGGESTED THAT THE CUSTOMER FOLLOW THE MATERIAL DATA SAFETY SHEET FROM THE OKI B4600 PRINTER AND SEEK MEDICAL ASSISTANCE FOR INHALATION ISSUES. TRACKING AND TRENDING IDENTIFIED NO NON-STATISTICAL TRENDS FOR THE CUSTOMER'S ISSUE. WHILE THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL DOES NOT CONTAIN INFORMATION REGARDING BREATHING ISSUES DUE TO TONER SPILLAGE, THE CUSTOMER IS INSTRUCTED TO FOLLOW THE PRINTER MANUAL FOR PROPER MAINTENANCE, INSTALLATION AND OPERATION. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED TONER SPILLED INSIDE AN OKIDATA B4600 PRINTER ATTACHED TO A CELL-DYN 1800 ANALYZER. THE CUSTOMER DONED A MASK AND VACUUMED THE SPILL. THE CUSTOMER NOTED TONER ON THE OUTSIDE OF THE MASK IMMEDIATELY AFTER VACUMMING, AND EXPERIENCED BREATHING AND WHEEZING ISSUES TWO DAYS LATER. THE CUSTOMER SCHEDULED AN APPOINTMENT WITH A MEDICAL PROVIDER. NO FURTHER INFORMATION IS AVAILABLE FROM THE CUSTOMER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LN 08H61-02| CARTRIDGE, PRINTER, OKI B4600, BLACK LN 08H61-02| CARTRIDGE, PRINTER, OKI B4600, BLACK