BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VP 2000 PROCESSOR

    MDR report key: 2370401 · Received April 4, 2011

    Report

    Report Number
    3005248192-2011-00002
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 7, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    KEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR REQUESTED THE RETURN OF THE INSTRUMENT WITH THE ALLEGED SHARP EDGES FOR COMPLAINT INVESTIGATION. THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION. ABBOTT MOLECULAR COMPLETED A SHARPNESS TEST ON A VP2000 INSTRUMENT CURRENTLY IN USE AT ABBOT MOLECULAR. THIS INSTRUMENT PASSED ON ALL USER ACCESSIBLE EDGES (PER UL STANDARD 1439).

    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. A CUSTOMER AND A FIELD SERVICE REPRESENTATIVE IN (B)(4) ALLEGED THAT THE METAL EDGES OF AN ABBOTT VP 2000 PROCESSOR (HEATER BLOCK, COVERS) UNIT ARE VERY SHARP. THE PARTS WITH EDGES THAT ARE ALLEGEDLY SHARP INCLUDE THE COVER FOR THE AMBIENT TEMPERATURE BATHS AND WHEN THE HEATED BASINS ARE REMOVED, THE OPENINGS OF THE HEATER REAGENT BASINS. DRYING STATION AND WATER BATH HAVE ALLEGEDLY SHARP EDGES ALSO. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1