APTIMA COMBO 2 ASSAY
Received Feb 24, 2014 · Event occurred Sep 23, 2013
Report 2024800-2014-00001 · MDR key 3643593
Device
Generic name
In-vitro Diagnostic Assay
Manufacturer
Gen-probe IncorporatedCatalog number
301032
Lot number
633593B
Product problems
- Improper or Incorrect Procedure or Method
Patient
33
- Exposure to Body Fluids
Narrative
Additional Manufacturer Narrative
DEVICE WAS NOT REPORTED TO BE DEFECTIVE.
Description of Event or Problem
A LAB TECH REPORTED THAT HE SPLASHED SPECIMEN IN HIS EYE WHILE PIPETTING REAGENT PRIOR TO PERFORMING AN IN-VITRO DIAGNOSTIC ASSAY FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS AND/OR NEISSERIA GONORRHOEAE. THE SPECIMEN WAS IN THE TESTING TUBE, AND WHILE ADDING PROBE REAGENT, THE SPECIMEN SPLASHED INTO HIS EYE. THE LAB TECH WAS NOT WEARING GOGGLES AS IS REQUIRED BY INSTRUCTIONS IN THE PACKAGE INSERT FOR THIS ASSAY. THE LAB TECH DID NOT KNOW WHAT TYPE OF SPECIMEN IT WAS, IT COULD BE URINE OR MATERIAL FROM A VAGINAL COLLECTION. THE LAB TECH SOUGHT MEDICAL ATTENTION AND WAS GIVEN ANTIBIOTICS.