BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLESTECH

    MDR report key: 1658817 · Received April 9, 2010

    Report

    Report Number
    2027969-2010-00440
    Event Type
    Malfunction
    Date Received
    April 9, 2010
    Date of Event
    March 19, 2010
    Report Date
    April 9, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    CHH
    PMA / PMN Number
    K901900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LDX PRINTER CAUGHT ON FIRE. NO INJURY OR DAMAGE TO SURROUNDING AREA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLESTECH PRINTER, THERMAL, 110V CHH BIOSITE INCORPORATED 11-781

    Patients

    Seq Age Sex Outcome Treatment
    1