SCIEX LCMSMS MASS SPECTROMETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-06 for SCIEX LCMSMS MASS SPECTROMETER manufactured by Sciex.

Event Text Entries

[91187701] Sciex mass spectrometer ic/ms/ms incorrect results. I'm a contracting nurse license since 2008 subject to dozens of tests and this test in particular on (b)(6) 2016 at a fastmed location in (b)(4). It was sent to (b)(4) for processing. This lab uses and was utilizing the recalled sciex mass spectrometers. My test results were reported as positive to employer. I was not notified, but employer notified board of nursing. Subsequently my license has been revoked in the state of (b)(6) and i'm facing revocation, every other state i have been licensed in as well. Plus, federal sanctioning from medicare programs. It's not an adverse medical event, per se, but it's an adverse event nonetheless as self-sufficiency and livelihood are completely incapacitated. Thank you for the notification you released on (b)(6) 2017. I hope that there is more aggressive outreach of this news. I'm sure i'm not the only one who's been subjected to this an i need advocacy getting the news out. Being a nurse in my absolute destiny and having it taken away from me has impacted me physically, financially and emotionally in the most devastating fashion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5073148
• MDR Report Key: 7002939
• Date Received: 2017-11-06
• Date of Report: 2017-11-02
• Date of Event: 2016-01-23
• Date Added to Maude: 2017-11-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SCIEX LCMSMS MASS SPECTROMETER
• Generic Name: SCIEX LCMSMS MASS SPECTROMETER
• Product Code: DOP
• Date Received: 2017-11-06
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SCIEX
• Manufacturer Address: US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-11-06