APTIMA COMBO 2 ASSAY ON TIGRIS DTS SYSTEM
Received Aug 3, 2016 · Event occurred Jul 6, 2016
Report 2024800-2016-00020 · MDR key 5843823
Device
Product problems
- Device Emits Odor
- Contamination /Decontamination Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Description of Event or Problem
ENVIRONMENTAL HEALTH MANAGER REPORTED THAT FIVE EMPLOYEES HAD COMPLAINED ABOUT BLEACH SMELL. ONE OF THE EMPLOYEES HAD TO SEEK MEDICAL ATTENTION FROM A DOCTOR. THE EMPLOYEE DID NOT SEE A DOCTOR DUE TO LONG WAIT TIME. DUE TO A CONTAMINATION EVENT HOLOGIC FAS HAD CLEANED THE LAB WITH DILUTED BLEACH AS PER THE PACKAGE INSERT. FSE MANAGER VISITED THE SITE AND WIPED DOWN ALL THREE TIGRIS INSTRUMENTS WITH DI WATER AND STATED THAT THERE WAS NO FURTHER BLEACH SMELL.