BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 6056280 · Received October 26, 2016

    Report

    Report Number
    2919069-2016-02247
    Event Type
    Injury
    Date Received
    October 26, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    UDI-DI
    00380740017170
    PMA / PMN Number
    K061667
    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 IN PROCESS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INCLUDED REVIEW OF PRODUCT HISTORICAL DATA, PRODUCT LABELING AND CONSULTATION WITH MEDICAL AFFAIRS. 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. IT IS UNKNOWN IF THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (GLOVES, SAFETY GLASSES, AND LAB COAT) BECAUSE REPEATED REQUESTS FOR INFORMATION WAS UNSUCCESSFUL. THE RETROVIRAL TREATMENT IS JUSTIFIED, AS IT HAS BEEN SHOWN TO SUCCESSFULLY PREVENT HIV INFECTION IN AT-RISK SUBJECTS. THE RISK FOR INFECTION, HOWEVER, IS LOW, AS THE PROBE GETS RINSED AFTER EVERY ASPIRATION. THE PRODUCT LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE CELL-DYN RUBY OPERATOR'S MANUAL PROVIDES WARNING FOR POTENTIAL BIOHAZARDS WHEN HANDLING ASPIRATION PROBES AND VENT NEEDLES, SUCH AS WEAR LAB COATS, PROTECTIVE EYEWEAR, GLOVES AND FOLLOW BIOSAFETY PRACTICES. BASED ON THE INVESTIGATION, THE INCIDENT WAS DUE TO A USE ERROR FOR POSSIBLE FAILURE TO FOLLOW THE WARNINGS IN PRODUCT LABELING WHICH COULD HAVE PREVENTED THE INCIDENT DURING HANDLING OF THE ASPIRATION PROBE. THE CELL-DYN RUBY ANALYZER IS PERFORMING ACCEPTABLY.

    Description of Event or Problem · 1

    THE OPERATOR STATED THE PROBE WAS REMOVED FROM THE CELL-DYN RUBY DURING TROUBLESHOOTING. THE OPERATOR PLACED THE PROBE IN ITS BOX FOR STORING WHEN HE ACCIDENTALLY HURT HIMSELF WITH THE PROBE. THE OPERATOR DID NOT RECEIVE ANY DISABILITY BUT WAS TREATED WITH RETROVIRAL DRUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708268 CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION 00380740017170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention