BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXFLX SYSTEM

    MDR report key: 902062 · Received August 24, 2007

    Report

    Report Number
    1628664-2007-00399
    Event Type
    Malfunction
    Date Received
    August 24, 2007
    Date of Event
    June 5, 2007
    Report Date
    July 27, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LCQ
    PMA / PMN Number
    K904226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOUR RETURNED TDX/TDXFLX TAFX VALVE BLOCKS WERE VISUALLY EXAMINED AND WERE FOUND TO BE TAFX VALVE BLOCKS IN TAFX VALVE BLOCK PACKAGING, LABELED WITH MANUFACTURING CODE 39.05, WITH IMX MULTIVALVE BLOCK LABELS ATTACHED TO THE FRONT OF THE VALVE BLOCKS. THE DATE CODE STAMP OF 39.05 INDICATES A MANUFACTURING DATE OF THE 39TH WEEK OF 2005 (THE WEEK OF SEPTEMBER 26, 2005). CUSTOMER COMPLAINT REVIEW FROM JANUARY 1, 2004 TO AUGUST 1, 2007 IDENTIFIED THREE ADD'L COMPLAINTS FOR TAFX VALVE BLOCKS MISLABELED WITH IMX MULTIVALVE BLOCK LABELS AND THIS ISSUE WAS PREVIOUSLY INVESTIGATED. THE TAFX VALVE BLOCKS WERE QUARANTINED. THE MANUFACTURER, FESTO CORPORATION, INSPECTED THE PRODUCT IN STOCK FOR THIS ISSUE AND NO ADD'L INSTANCES OF THIS ISSUE WERE IDENTIFIED. THE TAFX VALVE BLOCK HAS BEEN INCLUDED ON THE INSPECTION REQUIRED LIST AT THE MANUFACTURER. THE PART NUMBER WILL REMAIN ON THE LIST UNTIL A MINIMUM OF THREE LOTS OF MATERIAL HAVE BEEN ACCEPTABLY PRODUCED. IN ADDITION, IF NON-CONFORMING MATERIAL IS IDENTIFIED WITH THIS ISSUE, ADD'L ACTION(S) WILL BE CONSIDERED. THE MISLABELED TAFX VALVE BLOCK COULD BE INSTALLED ON AN IMX ANALYZER, BUT WOULD NOT BE ABLE TO PERFORM PRIMES OR ASSAY RUNS, SINCE THE TAFX VALVE BLOCK DOES NOT HAVE THE PORT #2 NEEDED FOR THE IMX. THERE WAS NO NEW DEFICIENCY FOUND DURING THE TRENDING REVIEW (JUNE 2007) CONCERNING THE IMX AND TDXFLX SYSTEMS THAT WOULD SUGGEST THAT THE USE OF THIS PRODUCT WOULD CAUSE SOME TYPE OF ADVERSE HEALTH CONSEQUENCE OR THAT THE PRODUCT IS PERFORMING CONTRARY TO INTENDED USE OR LABEL CLAIMS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED FOUR TAFX VALVE BLOCKS, LIST NUMBER 09520-15, WITH IMX MULTIVALVE BLOCK LABELS AFFIXED. THESE VALVE BLOCKS WERE RECEIVED ON 05/23/06 IN TAFX VALVE BLOCK PACKAGING. THE CUSTOMER VERIFIED THE PRODUCTS WERE TDX VALVE BLOCKS (ONE PORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDXFLX SYSTEM AUTOMATED FPIA ANALYZER LCQ ABBOTT MANUFACTURING, INC. NA 39.05

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR IMX ANALYZER LIST #8389-01