BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 4373517 · Received December 9, 2014

    Report

    Report Number
    4373517
    Date Received
    December 9, 2014
    Date of Event
    September 20, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    JJF
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN INCORRECT REAGENT WAS INADVERTENTLY LOADED ON ONE OF THE ROCHE ANALYZERS IN THE MAIN CHEMISTRY LAB. THIS WAS DISCOVERED 3 DAYS LATER, WHEN THE QC WAS OUT DURING START UP. ALL TESTING WAS IMMEDIATELY HALTED AND SERVICE CALL WAS MADE TO CLEAN AND RESTART W/ CORRECT REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794159 * CHEMISTRY ANALYZER. JJF ROCHE DIAGNOSTICS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *