BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-REACTIVE PROTEIN (LATEX)

    MDR report key: 347104 · Received August 2, 2001

    Report

    Report Number
    1823260-2001-00166
    Event Type
    Malfunction
    Date Received
    August 2, 2001
    Date of Event
    August 1, 2001
    Report Date
    August 2, 2001
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NOTIFIED BY GLOBAL AFFILIATE THAT REAGENT CASSETTES MAY CONTAIN UNDER-FILLED OR NEARLY EMPTY REAGENT BOTTLES. ANALYZER DOES NOT CONTAIN LEVEL DETECTION SYSTEM THEREFORE NO ALARM WOULD WARN CUSTOMERS. PATIENT SAMPLES AND CONTROLS MAY PRODUCE FALSELY LOW OR HIGH RESULTS WITHOUT AN ALARM OR THERE COULD BE UNACCEPTABLE PRECISION WHEN PATIENT OR CONTROL MATERIAL IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35018 C-REACTIVE PROTEIN (LATEX) REAGENT CASSETTE DCK ROCHE DIAGNOSTICS NA 156081-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O