BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 6945237 · Received October 12, 2017

    Report

    Report Number
    2919069-2017-00139
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 19, 2017
    Report Date
    November 13, 2017
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740016616
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS FLUSHING WATER THROUGH TUBING ON THE CELL-DYN SAPPHIRE INSTRUMENT, SERIAL NUMBER (B)(4), TO REMOVE A CLOT IN THE DILUTION CUP WHEN SOME LIQUID SPRAYED IN HER EYE. THE EMPLOYEE WENT TO THE MEDICAL CENTER TO HAVE THE EYE CHECKED. THERE WAS NO TREATMENT PROVIDED. UPON A REQUESTED SITE VISIT BY FIELD SERVICE THE CLOGGING ISSUE WAS RESOLVED. THE PERFORMANCE OF THE ANALYZER WAS NOT AFFECTED BY THIS INCIDENT. WHEN THE INCIDENT OCCURRED, THE OPERATOR WAS USING A LABORATORY COAT, GLOVES, AND HER OWN PRESCRIPTION EYEGLASSES. A REVIEW OF THE CELL-DYN SAPPHIRE OPERATOR'S MANUAL, PROTECTIVE EYEWEAR SHOULD BE USED WHEN OPERATING OR TROUBLESHOOTING THE INSTRUMENT (I.E. SAFETY GLASSES). IN THIS CASE, THE OPERATOR WAS NOT USING THE SUGGESTED PROTECTIVE EYEGLASSES. A REVIEW OF TICKETS FOR THE CELL DYN SAPPHIRE DID NOT IDENTIFY ANY SIMILAR COMPLAINTS AND NO TRENDS FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED FOR THE CELL DYN SAPPHIRE ANALYZER, SN (B)(4) OR THE PINCH TUBING KIT, LIST NUMBER 9130687.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER WAS FLUSHING WATER THROUGH TUBING ON THE CELL DYN SAPPHIRE TO REMOVE A CLOT IN THE DILUTION CUP WHEN SOME SPRAYED IN THEIR EYE. THE EMPLOYEE WAS WEARING A LABCOAT, GLOVES AND THEIR OWN PRESCRIPTIVE GLASSES. THE FEMALE EMPLOYEE (NOT PREGNANT) WENT TO THE MEDICAL CENTER TO HAVE THE EYE CHECKED. THERE WAS NO TREATMENT PROVIDED BUT THE EMPLOYEE WAS DRAWN TO BE TESTED FOR (B)(6). THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725844 CELL-DYN SAPPHIRE ANALYZER CELL-DYN SAPPHIRE ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740016616

    Patients

    Seq Age Sex Outcome Treatment
    1