BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROLAB AT PLUS 2

    MDR report key: 883681 · Received September 28, 2006

    Report

    Report Number
    2915796-2006-00006
    Event Type
    Malfunction
    Date Received
    September 28, 2006
    Date of Event
    August 4, 2006
    Report Date
    September 28, 2006
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR DISTRIBUTOR FOR THE DEVICE, ROCHE DIAGNOSTICS, HAS INVESTIGATED THIS EVENT AND HAS EVALUATED THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE A BURNED OUT CONTROLLER BOARD FOR THE BARCODE SCANNER. THE INSTRUMENT HAS BEEN REPAIRED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    HAMILTON CO WAS INFORMED OF AN EVENT THAT OCCURRED IN 2006, IN WHICH THE HAMILTON MICROLAB AT +2 INSTRUMENT REPORTEDLY EMITTED A BURNING SMELL. NO DEATH OR INJURY RESULTED FROM THIS EVENT. THIS REPORT IS ASSOCIATED WITH HAMILTON CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROLAB AT PLUS 2 MICROTITER DILUTING/DISPENSING JTC HAMILTON BONADUZ AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other