BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHOLESTECH LDX CHOLESTEROL ANALYZER

    MDR report key: 451615 · Received March 28, 2003

    Report

    Report Number
    MW1028013
    Event Type
    Injury
    Date Received
    March 28, 2003
    Report Date
    March 28, 2003
    Manufacturer
    CHOLESTECH CORP.
    Product Code
    JJQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROBLEM WITH PRODUCT RELIABILITY. CHOLESTECH LDX CHOLESTEROL ANALYZER. DESPITE NUMEROUS PHONE CALLS AND TECH REP VISITS AND EXCHANGE TO ANOTHER MACHINE, THE RESULTS ARE VERY UNRELIABLE, AND HAVE LED TO PTS GETTING THE WRONG DOSE OF MEDICATION. IN SOME CASES, THE PT MAY NOT HAVE EVEN NEEDED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLESTECH LDX CHOLESTEROL ANALYZER ANALYZES LIPID PROFILES JJQ CHOLESTECH CORP. CHOLESTECH LDX *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention