BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 2191967 · Received August 4, 2011

    Report

    Report Number
    2919069-2011-00533
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Removal / Correction Number
    2919069-3/15/11-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED DATE IN THE INITIAL REPORT WAS UNINTENTIONALLY LEFT BLANK. DATE SHOULD HAVE BEEN (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONSEQUENCES OR IMPACT TO PATIENT. (B)(4): NO PATIENT INVOLVEMENT. (B)(4): DEVICE MISASSEMBLED DURING MANUFACTURING OR SHIPPING. AN EXPANDED INVESTIGATION WAS CONDUCTED TO EVALUATE THIS ISSUE. A PRODUCT CORRECTION LETTER AND CUSTOMER REPLY FORM WILL BE SENT TO ALL ACTIVE CELL-DYN SYSTEM CUSTOMERS WHO RECEIVED THE AFFECTED PART NUMBERS. THE PRODUCT CORRECTION LETTER WILL INSTRUCT CUSTOMERS TO RETURN THE CUSTOMER REPLY FORM TO ABBOTT ACKNOWLEDGING THE RECEIPT AND UNDERSTANDING THE ISSUE OR REQUEST ASSISTANCE. THE NON-CONFORMING PARTS WILL BE REPLACED IN THE FIELD THROUGH A FOUR-MONTH MANDATORY TECHNICAL SERVICE BULLETIN (TSB) ISSUED FOR EACH OF THE CELL-DYNS INVOLVED.

    Description of Event or Problem · 1

    THE CUSTOMER HAD THE CELL-DYN SHEAR VALVE DRIVER REPLACED PER (B)(4). NO IMPACT TO PATIENT RESULTS, PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEAR VALVE DRIVER