BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD CLEANER

    MDR report key: 5610017 · Received April 26, 2016

    Report

    Report Number
    2919069-2016-00418
    Event Type
    Malfunction
    Date Received
    April 26, 2016
    Date of Event
    April 1, 2016
    Report Date
    July 5, 2016
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K081495
    Removal / Correction Number
    2919069-03/24/16-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORECT THE SUSPECT MEDICAL DEVICE MANUFACTURE LOCATION. THE WRONG LOCATION WAS DOCUMENTED IN THE FOLLOW UP RPEORT TO 2919069-2016-00418 - 01. REPORT ABOVE HAS BEEN UPDATED TO REFLECT THE CORRECT LOCATION. NO OTHER CHANGES HAVE BEEN DOCUMENTED IN THIS REPORT. THE INVESTIGATION TO DETERMINE CAUSE IS STILL ONGOING; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN CAUSE IS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). A PRODUCT RECALL LETTER WAS ISSUED TO ALL CELL-DYN EMERALD CUSTOMERS WHO HAVE RECEIVED CELL-DYN EMERALD CLEANER (LOTS 6853, 6901, 6953). THE LETTER INFORMS THE CUSTOMER OF THE ISSUE REGARDING THE POTENTIAL FOR OUT OF RANGE CONTROLS. THE LETTER INSTRUCTS THE CUSTOMER TO DISCONTINUE USE OF THE SUSPECTED LOT AND DESTROY ANY REMAINING INVENTORY. THE CUSTOMER IS INSTRUCTED THAT IF THEY DO NOT HAVE REPLACEMENT MATERIAL AVAILABLE, THEY CAN CONTINUE TO USE THE LOT UNTIL THEY RECEIVE REPLACEMENT MATERIAL AS LONG AS THEIR CONTROLS ARE IN RANGE. THE CUSTOMER IS INSTRUCTED TO PERFORM THE DECONTAMINATION PROCEDURE PER THE OPERATOR'S MANUAL. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN CAUSE IS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    FA24MAR2016 HAS BEEN EXPANDED TO INCLUDE CELL-DYN EMERALD CLEANER LOT NUMBERS 7044, 7082, 7110 AND 7119. THE CAUSE FOR THE QC MATERIAL OUT-OF-RANGE LOW ISSUE HAS BEEN TRACED TO THE MANUFACTURING PROCESS FOR RAW MATERIAL USED IN THE CELL-DYN EMERALD CLEANER.

    Additional Manufacturer Narrative · 1

    FA24MAR2016 HAS BEEN EXPANDED TO INCLUDE CELL-DYN EMERALD CLEANER LOT NUMBERS 6991, 7024 AND 7027. THE INVESTIGATION TO DETERMINE CAUSE IS STILL ONGOING; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN CAUSE IS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER WAS EXPERIENCING PLT CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 6901. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265488 CELL-DYN EMERALD CLEANER CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION 6901

    Patients

    Seq Age Sex Outcome Treatment
    1