BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VP 2000 PROCESSOR

    MDR report key: 1828148 · Received September 8, 2010

    Report

    Report Number
    3005248192-2010-00005
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 20, 2010
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR INC. IS AWARE OF THE PROBLEM WITH THE VP 2000 PROCESSOR BASINS. AN URGENT PRODUCT RECALL (3005248192-06/18/2010-001-C) WAS DISTRIBUTED VIA (B)(6) SHIPMENT TO UNITED STATES CUSTOMERS BASED ON CUSTOMER RECEIPT OF VP 2000 PROCESSOR AND BASIN SPARE PART SINCE (B)(6) 2008. A MDR (3005248192-2010-0002) WAS ALSO FILED ON JULY 02, 2010. THREE POTENTIAL HAZARDS WERE IDENTIFIED: DELAY IN RESULTS. THERE IS NO HARM ASSOCIATED WITH THIS HAZARD CHEMICAL EXPOSURE. THERE IS NO HARM ASSOCIATED WITH THIS HAZARD AS THIS ISSUE DOES NOT INCREASE THE ALREADY EXPECTED EXPOSURE TO THESE REAGENTS. THEREFORE, THERE IS NO INTRODUCED OPERATOR HARM. SLIP HAZARD. EVALUATION DETERMINED THAT THE OVERALL HEALTH RISK WAS LOW, BASED ON THE FOLLOWING: A. THE OVERALL ESTIMATE FOR A LEAKING BASIN WAS 1.1% (BASED ON BASINS KNOWN TO BE RELATED TO THIS ISSUE) B. 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 HOURS), THE LEAKED LIQUID WILL BE LESS THAN 50 ML C. SLIP HAZARD WILL BE AVOIDED BY THE OPERATOR'S OBSERVANCE OF THE LIQUID ON THE FLOOR AND BY THE SMALL VOLUME OF LIQUID. I. IF A LEAK WERE TO OCCUR, IT WOULD OCCUR IN AN AREA THAT A LAB OPERATOR WOULD NOT NORMALLY WALK (IN THE VP2000) OR DURING REAGENT ADDITION (LAB BENCH). IN ADDITION, THE LEAK WOULD BE VISUALLY OBVIOUS TO THE OPERATOR. D. IF THE OPERATOR DID STEP ON THE LEAK, IT WOULD NOT NECESSARILY LEAD TO A FALL THAT WOULD LEAD TO A SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, THROUGH AN INTERNAL AUDIT INVESTIGATION IT WAS DISCOVERED THAT THE DATE INCLUDED IN THE ORIGINAL MDR REPORT WAS INCORRECT. THE PURPOSE OF THIS MDR FOLLOW-UP REPORT #1 IS TO UPDATE THE ORIGINAL INCORRECT DATE FROM (B)(6) 2010 TO THE CORRECT DATE (B)(6) 2010.

    Description of Event or Problem · 1

    THE ABBOTT VP 2000 PROCESSOR IS A DEVICE DESIGNED TO AUTOMATE AND STANDARDIZE SLIDE SPECIMEN PROCESSING AND ROUTINE SLIDE STAINING FOR THE LABORATORY. CUSTOMER CALLED IN REGARDS TO THE PRODUCT RECALL NOTIFICATION FOR POTENTIAL VP 2000 PROCESSOR LEAKING BASINS AND INDICATED THAT THEY HAVE LEAKING BASINS. THE CUSTOMER HAS 5 BASINS BETWEEN 2 MACHINES. THE NOTIFICATION ASKED FROM CUSTOMERS TO TAKE THE FOLLOWING ACTION: "IF YOU NOTICE LEAKING OR WARPED BASINS OR AN INABILITY TO PLACE THE BASINS INTO THE VP 2000 PROCESSOR, PLEASE CALL YOUR LOCAL ABBOTT MOLECULAR REPRESENTATIVE FOR COORDINATION OF BASIN REPLACEMENT. AN ABBOTT MOLECULAR CUSTOMER SERVICE REPRESENTATIVE OR FIELD SERVICE REPRESENTATIVE WILL BE CALLING YOU TO COORDINATE REPLACEMENT OF YOUR VP 2000 HEATED REAGENT BASINS BEFORE (B)(6) 2010. PLEASE NOTE THAT ADDITIONAL MEASURES HAVE BEEN TAKEN TO ENSURE CURRENTLY AVAILABLE INVENTORY DOES NOT EXHIBIT THIS ISSUE." ABBOTT MOLECULAR DISTRIBUTED AN 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. A MDR (3005248192-2010-0002) WAS ALSO FILED ON JULY 02, 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1