BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VP2000

    MDR report key: 1446355 · Received May 26, 2009

    Report

    Report Number
    3005248192-2009-00002
    Event Type
    Malfunction
    Date Received
    May 26, 2009
    Date of Event
    April 27, 2009
    Report Date
    May 22, 2009
    Manufacturer
    ABBOTT MOLECULAR
    Product Code
    KEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR HAS COMPLETED A ROOT CAUSE INVESTIGATION OF THIS VP2000 HEATING ISSUE. (B) (4). THE ENGINEERING GROUP IS CONSIDERING SEVERAL OPTIONS TO CHANGE THE VP2000 HARDWARE IN ORDER TO CORRECT THIS OVERHEATING ISSUE. PLEASE NOTE THAT THIS ISSUE HAS BEEN PREVIOUSLY REPORTED UNDER MDR 3005248192-2009-0003. ABBOTT MOLECULAR ALSO CONDUCTED A RECALL, (B) (4), REGARDING THIS VP2000 HEATER AND ACKNOWLEDGED RECEIPT OF THE RECALL NOTICE. ADDITIONAL MODEL #'S: -04, -60.

    Description of Event or Problem · 1

    A NEW COMPLAINT HAS BEEN RECEIVED ON AN ISSUE PREVIOUSLY REPORTED UNDER REPORT NUMBER 3005248192-0003. THIS NEW COMPLAINT ENTAILS A COMMUNICATION FROM A CUSTOMER THAT REPORTS THAT THE VP2000 IS OVERHEATING. (B) (4). THIS CUSTOMER WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VP2000 VP2000 SLIDE SPECIMEN PROCESSOR KEY ABBOTT MOLECULAR 2J11-01

    Patients

    Seq Age Sex Outcome Treatment
    1