BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 2900415 · Received January 7, 2013

    Report

    Report Number
    2919069-2013-00003
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED A CELL-DYN SAPPHIRE ANALYZER MISREAD SAMPLE ID (B)(6). A FIELD SERVICE ENGINEER PERFORMED AUTO-LOADER SAMPLE BAR CODE CLEANING AND SCANNED THE SAMPLE ID AGAIN AND FOUND NO ERRORS. THE ENGINEER COULD NOT REPORDUCE THE ISSUE REPORTED BY THE CUSTOMER. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TRENDS FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE EVENT DETAILS AND THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A CELL-DYN SAPPHIRE ANALYZER MISREAD SAMPLE ID (B)(6). THE INCORRECT SAMPLE ID WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6181 CELL-DYN SAPPHIRE ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 BARCODE READER, SCANNER, (B)(4)| BARCODE READER, SCANNER, (B)(4)