BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLESTECH LDX ANALYZER

    MDR report key: 2082620 · Received April 27, 2011

    Report

    Report Number
    2027969-2011-00935
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    CHH
    PMA / PMN Number
    K0901900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED THAT WHEN SHE PUSHED THE CHOLESTECH LDX DATA BUTTON, THE ANALYZER SHOCKED HER AND THEN WENT DEAD. CUSTOMER STATES THE SHOCK SOUNDED LIKE A LOUD POP THAT COULD BE HEARD THROUGHOUT THE ROOM. ANALYZER WOULD NOT TURN BACK ON AFTERWARD. CUSTOMER HAS NOT NOTICED ANY FRAYING OR DAMAGE TO THE POWER CORD. NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1