BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VP 2000 PROCESSOR

    MDR report key: 2796733 · Received December 30, 2010

    Report

    Report Number
    3005248192-2010-00012
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    KEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 [Z-2313-2010] WAS DISTRIBUTED VIA (B)(4) SHIPMENT TO UNITED STATES CUSTOMERS BASED ON CUSTOMER RECEIPT OF VP 2000 PROCESSOR AND BASIN SPARE PART SINCE (B)(4) 2008. THE RECALL WAS CONCLUDED IN THE UNITED STATES IN OCTOBER, 2010; ALL LEAKING BASINS WERE REPLACED ALL NON-LEAKING BASINS WERE INSPECTED BY ABBOTT FIELD SERVICE PERSONNEL. BASED ON THIS ADD'L COMPLAINT, ANOTHER URGENT PRODUCT RECALL WAS ISSUED FA CAM-DEC2010-093. THIS RECALL WILL COORDINATE REPLACEMENT OF ALL VP 2000 HEATER BASINS IMPACTED BY THIS MFG ISSUE. THE FOLLOWING MDRS WERE ALSO FILED: MDR 3005248192-2010-0002, FILED ON (B)(4) 2010; 0005, 0006 FILED ON (B)(4) 2010; 0007, 0008 FILED ON (B)(4) 2010, 0011 FILED ON (B)(4) 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. EVAL DETERMINED THAT THE OVERALL HEALTH RISK WAS LOW, BASED ON THE FOLLOWING: THE OVERALL ESTIMATE FOR A LEAKING BASIN WAS (B)(4) (BASED ON BASINS KNOWN TO BE RELATED TO THIS ISSUE). LEAKING RATE IS EXPECTED TO BE ABOUT 1 TO 2 DROPS PER MIN < 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. SLIP HAZARD WILL BE AVOIDED BY THE OPERATOR'S OBSERVANCE OF THE LIQUID ON THE FLOOR AND THE SMALL VOLUME OF LIQUID. 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. IF THE OPERATOR DID STEP ON THE LEAK, IT WOULD NOT NECESSARILY LEAD TO A FALL THAT WOULD LEAD TO A SERIOUS INJURY.

    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 REPORTED HAVING A LEAKING BASIN. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VP 2000 PROCESSOR STAINER, TISSUE, AUTOMATED KEY ABBOTT MOLECULAR, INC. 02J11-001

    Patients

    Seq Age Sex Outcome Treatment
    1