BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL BILIRUBIN REAGENT-COBAS

    MDR report key: 266140 · Received February 24, 2000

    Report

    Report Number
    1823260-2000-00023
    Event Type
    Malfunction
    Date Received
    February 24, 2000
    Date of Event
    February 1, 2000
    Report Date
    February 11, 2000
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT MFR NOTIFIED ROCHE DIAGNOSTICS OF A CONCERN FOR THE TOTAL BILIRUBIN REAGENT, CATALOG 07 2748 8, LOT# 603 976-01. THE MFR REPORTED THE R1 BOTTLE WAS NOT COMPLETELY FILLED ON A LIMITED NUMBER OF CASSETTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL BILIRUBIN REAGENT-COBAS REAGENT FOR COBAS ANALYZER CIG ROCHE DIAGNOSTICS REAGENT- BILIRUBIN 603 976-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other