BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIPID CONTROL

    MDR report key: 129697 · Received November 4, 1997

    Report

    Report Number
    2050068-1997-00001
    Event Type
    Other
    Date Received
    November 4, 1997
    Date of Event
    October 16, 1997
    Report Date
    November 3, 1997
    Manufacturer
    MEDICAL ANALYSIS SYSTEMS, INC.
    Product Code
    JJY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CUT HAND ON BROKEN VIAL. CUSTOMER TESTED MAS PRODUCT AND REPORTED POSITIVE RESULTS FOR HCV, HBSAG, HBCOREAB. 10/17/97 BACKGROUND INVESTIGATION INDICATED ALL NEW MATERIALS USED IN PRODUCT TESTED NEGATIVE BY FDA APPROVED METHODS FOR HBSAG, HBCORE AB, AND POSITIVE FOR ANTI HCV. 11/3/97 MAS REFERRED CONFIRMATION TESTING BY PCR ALSO CONFIRMED POSITIVE HCV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPID CONTROL MULTI CONSTITUENT LABORATORY CONTROL (75JJY) JJY MEDICAL ANALYSIS SYSTEMS, INC. NA 9809-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other