BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLESTECH LDX

    MDR report key: 326760 · Received April 11, 2001

    Report

    Report Number
    MW1021594
    Event Type
    Malfunction
    Date Received
    April 11, 2001
    Date of Event
    November 1, 2000
    Report Date
    April 5, 2001
    Manufacturer
    CHOLESTECH CORP.
    Product Code
    JGY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CHOLESTEROL CASSETTE - NO REACTION WOULD OCCUR. CHOLESTEROL HIGH AND LOW CONTROLS WERE OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16515 CHOLESTECH LDX ANALYZER-CHOLESTEROL AND GLUCOSE JGY CHOLESTECH CORP. 05625 C08 3108 - 7 BOXES
    16516 CHOLESTECH LDX ANALYZER - CHOLESTEROL & GLUCOSE JGY CHOLESTECH CORP * C04 3211 - 22 BOXES
    16517 CHOLESTECH LDX ANALYZER - CHOLESTEROL & GLUCOSE JGY CHOLESTECH CORP. * C11 3208 - 27 BOXES

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other