BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD

    MDR report key: 8597767 · Received May 9, 2019

    Report

    Report Number
    2919069-2019-00056
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    March 5, 2019
    Report Date
    June 17, 2019
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Removal / Correction Number
    2919069-05/09/19-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE, SERIAL NUMBER CONTINUED: 007689-007809 AND 007813-007814 THIS REPORT IS BEING SUBMITTED TO ADD. UDI # = (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE, SERIAL NUMBER CONTINUED: (B)(4). THIS REPORT IS BEING SUBMITTED TO CORRECT THE TYPE OF REPORT. 7-DAY SELECTED IN ERROR. 30- DAY SHOULD BE MARKED.

    Additional Manufacturer Narrative · 1

    THIS FIELD ACTION IS ASSOCIATED WITH CELL-DYN EMERALD INSTRUMENT SERIAL NUMBERS ENDING IN (B)(4), (B)(4), AND (B)(4) (LIST NUMBER 09H39-01) AND SPARE KITS OF THE EMERALD DILUENT TUBING (LIST NUMBER 09H50-01) SERIAL/CONTROL NUMBER (B)(4). A PRODUCT RECALL LETTER HAS BEEN ISSUED TO ALL CUSTOMERS WHO HAVE INSTALLED INSTRUMENTS WITH THE IMPACTED SERIAL NUMBERS AND CUSTOMERS WHO HAVE RECEIVED THE IMPACTED EMERALD DILUENT TUBING. THE LETTER INFORMS THE CUSTOMER OF THE FOLLOWING: - ABBOTT REPRESENTATIVE WILL BE CONTACTING THEM TO SCHEDULE AN APPOINTMENT TO REPLACE THE TUBING - THE CUSTOMER MAY CONTINUE TO OPERATE THEIR INSTRUMENT PER THE REQUIREMENTS OUTLINED IN SECTION 5 OF THE OPERATORS MANUAL, "BACKGROUND COUNTS MUST BE WITHIN ACCEPTABLE LIMITS BEFORE RUNNING CONTROLS OR PATIENT SPECIMENS" AND "ALL DATA SHOULD BE CONSIDERED FOR PATIENT CARE MANAGEMENT. IF THE RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT."

    Description of Event or Problem · 1

    ABBOTT LABORATORIES WAS NOTIFIED OF A SUPPLIER ISSUE REGARDING THE DILUENT TUBING THAT IS PLACED INSIDE THE REAGENT CONTAINER ON CELL-DYN EMERALD INSTRUMENT SERIAL NUMBERS ENDING IN (B)(4), (B)(4), AND (B)(4) AS WELL AS SPARE KITS OF THE EMERALD DILUENT TUBING USED FOR REPLACEMENT. THE TUBING APPEARS CLOUDY OR TO HAVE A POWDER/FILM ON THE INNER AND OUTER SURFACES. THIS ISSUE MAY POTENTIALLY LEAD TO FALSELY ELEVATED PLATELET (PLT) RESULTS. THERE HAS BEEN NO REPORTED PATIENT HARM DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391097 CELL-DYN EMERALD AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 EMERALD DILUENT TUBING, LN 09H50-01,| EMERALD DILUENT TUBING, LN 09H50-01,| EMERALD DILUENT TUBING, LN 09H50-01,| SERIAL/CONTROL NUMBER (B)(4)| SERIAL/CONTROL NUMBER (B)(4)| SERIAL/CONTROL NUMBER (B)(4)