BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLESTECH

    MDR report key: 2010242 · Received February 11, 2011

    Report

    Report Number
    2027969-2011-00292
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    CHH
    PMA / PMN Number
    K901900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES NOTICING A SCORCH MARK ON THE METER AND ROM PACK WHILE REMOVING AN OLD ROM PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLESTECH CHOLESTEROL METER CHH ALERE SAN DIEGO, INC. 10-004

    Patients

    Seq Age Sex Outcome Treatment
    1