BEUDAMED
    FDA Adverse Event Summary report: N

    CHOLESTEROL TEST

    MDR report key: 16865 · Received October 17, 1994

    Report

    Report Number
    MW1003705
    Date Received
    October 17, 1994
    Report Date
    October 13, 1994
    Manufacturer
    ADVANCED CARE PRODUCTS
    Product Code
    CGO
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE UNIT IS SOLD FOR ONE DETERMINATION OF TOTAL BLOOD CHOLESTEROL. THE UNIT HAS NO CONTROLS. THE ONLY ASSURANCE OF 97% ACCURACY AS STATED BY THE COMPANY IS THE COMPANY'S WORD. THE RPTR QUESTIONS HOW ONE CAN KNOW IF THE TEST IS ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLESTEROL TEST CGO ADVANCED CARE PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 *