inforMED
InjuryDOP

AGILENT 7000 C GC/MS TRIPLE QUAD

Received Jun 13, 2023 · Event occurred Jul 23, 2020

Report MW5118386 · MDR key 17128481

Device

Generic name

Mass Spectrometer, Clinical Use

Product problems

  • Therapeutic or Diagnostic Output Failure

Patient

43 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

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.