BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 7101591 · Received December 8, 2017

    Report

    Report Number
    2919069-2017-00165
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    November 14, 2017
    Report Date
    January 15, 2018
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740016616
    PMA / PMN Number
    K051215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF PRODUCT HISTORICAL DATA FOR ANY TRENDS AND ALL CUSTOMER COMPLAINTS RECEIVED FOR THIS ISSUE DID NOT IDENTIFY ANY ADVERSE TRENDS OR ABNORMAL COMPLAINT ACTIVITY. PER COMPLAINT INFORMATION, THE FIELD SERVICE REPRESENTATIVE (FSR) WAS MOVING THE INSTRUMENT THAT WAS NOT IN USE INTO ANOTHER SUITABLE LOCATION IN THE LAB. THE FSR TURNED ON THE INSTRUMENT AND DURING PRIME CYCLE LIQUID COMING FROM THE DILUTION CUPS SQUIRTED INTO HIS FACE AND LEFT EYE. HE WAS NOT ABLE TO DETERMINE WHICH OF THE 3 DILUTION CUPS GENERATED THE LIQUID THAT SPLASHED ON HIS FACE AND LEFT EYE. THE FSR PERFORMED THE RECOMMENDED FIRST AID ACTION BY WASHING HIS FACE AND LEFT EYE WITH ABUNDANT WATER FOR 10-15 MINUTES, AND CONSULTING A DOCTOR FOR EXAMINATION. THE OPHTHALMOLOGY DOCTOR CONFIRMED THE CORNEA IS GOOD AND PRESCRIBED AN ANTI-INFLAMMATORY MEDICATION, ONE FOR LUBRICATING AND ANOTHER FOR INFLAMMATORY. THE FSR WAS WEARING GLOVES AND LABORATORY COAT BUT NOT PROTECTIVE EYEGLASSES. THE CELL-DYN SAPPHIRE HAS A CENTER COVER CALLED "NOSE COVER" WHICH SERVES AS A PROTECTIVE BARRIER FOR SUCH INCIDENT. IN ADDITION, THE SYSTEM OPERATOR'S MANUAL SUGGESTS THAT OPERATORS SHOULD WEAR PERSONAL PROTECTIVE EQUIPMENT, LAB COAT, GLOVES, AND PROTECTIVE EYEGLASSES. IN THIS CASE, THE INCIDENT MAY HAVE BEEN PREVENTED IF THE NOSE COVER WAS IN PLACE AND IF THE FSR HAD PROTECTIVE EYEGLASSES. REFER TO THE CELL-DYN SAPPHIRE OPERATOR'S MANUAL, SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS, THE MANUAL STATES: CONSIDER ALL CLINICAL SPECIMENS, REAGENTS, CALIBRATORS, AND CONTROLS THAT CONTAIN HUMAN-SOURCED MATERIALS AS POTENTIALLY INFECTIOUS. CONSIDER ALL SYSTEM SURFACES OR COMPONENTS THAT HAVE COME IN CONTACT WITH HUMAN SOURCED MATERIALS AS POTENTIALLY INFECTIOUS. REFER TO SECTION 8: HAZARDS, FOR ADDITIONAL INFORMATION. SECTION 8, HAZARDS, THE MANUAL STATES OPERATOR HAVE TO MAKE SURE THEY ARE WEARING EYE PROTECTION AND OTHER PERSONAL PROTECTIVE CLOTHING. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. USE ERROR CAUSED THE ISSUE AS THE FSR WAS NOT WEARING PROTECTIVE EYEGLASSES AND THE PROTECTIVE COVER OF THE INSTRUMENT WAS NOT INSTALLED IN THE INSTRUMENT AT THE TIME OF THE INCIDENT. TAKEN TOGETHER, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    DURING INSTALLATION OF THE CELL-DYN SAPPHIRE WHEN THE INSTRUMENT WAS TURNED ON A STREAM OF LIQUID WENT INTO THE OPERATOR'S EYE. THE OPERATOR WAS NOT WEARING PROTECTIVE EYE GLASSES. THE EYE HAD A BURNING SENSATION AND WAS IMMEDIATELY WASHED WITH WATER. MEDICAL CARE DETERMINED THE CORNEA WAS FINE WITH NO SIGN THAT ANYTHING BURNED. TWO MEDICATIONS WERE PRESCRIBED FOR THE EYE, ONE FOR LUBRICATING (CARBOXYMETHYL CELLULOSE SODIUM 0.5% GLYCERIN 0.9%) AND ANOTHER ANTI-INFLAMMATORY (FLUOROMETHOLONE 0.1%). NO OTHER IMPACT TO THE OPERATOR WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880401 CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 08H00-01 00380740016616

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention