BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE REAGENT

    MDR report key: 129041 · Received October 29, 1997

    Report

    Report Number
    129041
    Event Type
    Malfunction
    Date Received
    October 29, 1997
    Date of Event
    August 29, 1997
    Report Date
    September 12, 1997
    Manufacturer
    ROCHE DIAGNOSTIC SYSTEMS, INC.
    Product Code
    JIF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 8/29/97, LAB RECEIVED A FAX FROM THE MFR, NOTIFYING FACILITY THAT AMMONIA REAGENT WAS CAUSING FALSELY ELEVATED RESULTS. REAGENT WAS IN USE SINCE 8/16/97. PT WAS DIALYZED BASED ON LAB RESULTS. AMMONIA LEVEL WAS DONE 26 TIMES ON THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE REAGENT ROCHE REAGENT FOR AMMONIA JIF ROCHE DIAGNOSTIC SYSTEMS, INC. NA 29157 0015,29157 0017

    Patients

    Seq Age Sex Outcome Treatment
    1 18 DAY