BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN EMERALD CLEANER

    MDR report key: 5820152 · Received July 25, 2016

    Report

    Report Number
    2919069-2016-01585
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Report Date
    July 25, 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
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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, 6991, 7024, 7027, 7044, 7082, 7110 AND/OR 7119). 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 OPERATORS MANUAL. 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.

    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 7119. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474040 CELL-DYN EMERALD CLEANER CELL-DYN EMERALD GKZ ABBOTT DIAGNOSTICS DIVISION 7119

    Patients

    Seq Age Sex Outcome Treatment
    1