BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 ANALYZER

    MDR report key: 313333 · Received January 19, 2001

    Report

    Report Number
    1823260-2001-00009
    Event Type
    Malfunction
    Date Received
    January 19, 2001
    Report Date
    January 15, 2001
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SOME ANALYZER PIPETTE TIPS HAVE THE TIPS BLOCKED AND MAY PRODUCE INACCURATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2658 ELECSYS 2010 ANALYZER IMMUNOASSAY ANALYZER LCI ROCHE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *