BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VP 2000 PROCESSOR

    MDR report key: 1765576 · Received July 2, 2010

    Report

    Report Number
    3005248192-2010-00002
    Event Type
    Malfunction
    Date Received
    July 2, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 4, 2010
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    KPA
    Removal / Correction Number
    93005248192-06/18/2010-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4), 2012, THROUGH AN INTERNAL AUDIT INVESTIGATION IT WAS DISCOVERED THAT SOME DATES INCLUDED IN THE ORIGINAL MDR REPORT WERE INCORRECT. (B)(4).

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR TO DISTRIBUTE URGENT PRODUCT RECALL (3005248192-06/18/2010-001-C) VIA (B)(6) SHIPMENT TO UNITED STATES CUSTOMERS BASED ON CUSTOMER RECEIPT OF VP 2000 PROCESSOR AND BASIN SPARE PART SINCE (B)(6) 2008. TECHNICAL SERVICE BULLETIN WILL BE MADE AVAILABLE TO INSTRUCT FIELD SERVICE ENGINEERS TO INSPECT AND, IF NECESSARY, REPLACE HEATED BASINS. ADDITIONALLY, AS SPARE PART REPLACEMENT INVENTORY BECOMES AVAILABLE, (B)(4) TECHNICAL SERVICES MAY BEGIN EXECUTING TELEPHONE PROTOCOL AND PROVIDE REPLACEMENT BASINS SUFFICIENT FOR CUSTOMER TO DESTROY ALL CURRENT HEATED BASINS AND REPLACE WITH THOSE PROVIDED. TECHNICAL SERVICES WILL PROVIDE CUSTOMER REPLY FORM TO BE COMPLETED BY CUSTOMER AT TIME OF RECEIPT OF REPLACEMENT BASINS.

    Description of Event or Problem · 1

    THE ABBOTT VP 2000 PROCESSOR IS A DEVICE DESIGNED TO AUTOMATE AND STANDARDIZE SLIDE SPECIMEN PROCESSING ROUTINE SLIDE STAINING FOR THE LABORATORY. THE FOLLOWING DEFICIENCIES WERE IDENTIFIED IN THE COMPLAINT INVESTIGATION (TWO CUSTOMER COMPLAINTS FROM ONE CUSTOMER SITE) THAT COULD LEAD TO LEAKAGE FAILURES OR THE INABILITY TO RUN THE INSTRUMENT: THE BASINS EXHIBIT A CRACK ALONG THE BOTTOM SEAM AND NON-UNIFORM COATING IN THE INTERIOR CORNERS. THE BASINS EXHIBIT SEVERE WARPING OF THE ALUMINUM HOUSING. THE BASINS EXHIBIT INCORRECT DIMENSIONS WHEN PERFORMING SQUARENESS TEST. THERE IS NO HEALTH HAZARD ASSOCIATED WITH A DELAY OF RESULTS, HOWEVER, LEAKING COULD RESULT IN A SLIP HAZARD. THE OVERALL ESTIMATE FOR THIS FAILURE IS 1.1% (BASED ON BASINS KNOWN TO BE RELATED TO THIS ISSUE). LEAKING RATE IS EXPECTED TO BE ABOUT 1 TO 2 DROPS PER MINUTE (< 100 UL PER MIN). WHEN A LOADED BASIN IS EITHER USED IN THE VP2000 OR STORED ON THE LAB BENCH, IN THE TYPICAL USAGE TIME (< 8 HRS), THE LEAKED LIQUID WILL BE LESS THAN 50 ML. THE OVERALL RISK IS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VP 2000 PROCESSOR STAINER, TISSUE AUTOMATED KPA ABBOTT MOLECULAR, INC. MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1