BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILENT 7000 C GC/MS TRIPLE QUAD

    MDR report key: 17128481 · Received June 13, 2023

    Report

    Report Number
    MW5118386
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    July 23, 2020
    Report Date
    June 9, 2023
    Manufacturer
    AGILENT TECHNOLOGIES INC.
    Product Code
    DOP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    QUEST LABS REPORTED A D/L ISOMER TEST THAT HAD FAILED THE QUALITY CONTROLS CHECK ON THE AGILENT 7000C TRIPLE QUAD MS (MASS SPECTROMETER)/GC (GAS CHROMATOGRAPH). I HAVE THE ENTIRE 192-PAGE DOCUMENT WITH 5 CORRECTIVE ACTIONS AND NO PROOF THE MACHINE WAS FUNCTIONING PROPERLY. OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945298 AGILENT 7000 C GC/MS TRIPLE QUAD MASS SPECTROMETER, CLINICAL USE DOP AGILENT TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention VYVANSE, WELLBUTRIN, PSEUDOEPHEDRINE.