BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 3023751 · Received March 27, 2013

    Report

    Report Number
    2919069-2013-00034
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. BASED ON THE SUBMITTED DATA, THE POSSIBILITY OF SPECIMEN ID (B)(6) BEING MOVED FROM POSITION R14T1 TO R14T2 TO ACCOMOCATE A POSSIBLE STAT SAMPLE IN POSITION R14T1 COULD NOT BE ELIMINATED. THE SAMPLE RESULTS, SPECIMEN ID AND DEMOGRAPHICS FOR THE TWO SAMPLES IN QUESTION WERE DIFFERENT FROM EACH OTHER. THE COMPLAINT ISSUE OF "BOTH SAMPLES WERE IDENTIFIED WITH ONE SAMPLE INFORMATION" WAS FOUND TO BE INACCURATE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A CELL-DYN RUBY ANALYZER GENERATED A SAMPLE ID MISMATCH. TWO SAMPLES FROM TWO DIFFERENT PATIENTS WERE PLACED IN POSITIONS 1 AND 2 IN A SAMPLE RACK. BOTH REPORTS WERE GENERATED WITH THE SAMPLE INFO FROM ONLY ONE OF THE PATIENTS. THE DATALOG AND ANALYZER REPORTS WERE REQUESTED FROM THE CUSTOMER BUT NOT YET PROVIDED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125964 CELL-DYN RUBY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1