BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD CLEANER

    MDR report key: 5588422 · Received April 20, 2016

    Report

    Report Number
    2919069-2016-00279
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    March 16, 2016
    Report Date
    June 29, 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
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    (B)(4) (NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT). (B)(4) (LOW TEST RESULTS). A PRODUCT RECALL LETTER WAS ISSUED TO ALL CELL-DYN EMERALD CUSTOMERS WHO HAVE RECEIVED CELL-DYN EMERALD CLEANER, LOTS (6853, 6901, AND 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

    PMA 510(K) NUMBER SHOULD HAVE BEEN K081495 AND HAS BEEN DOCUMENTED CORRECTLY.

    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. AN EVALUATION IS STILL IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER WAS EXPERIENCING RBC CONTROL VALUES 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
    247973 CELL-DYN EMERALD CLEANER CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION 6901

    Patients

    Seq Age Sex Outcome Treatment
    1