VERSANT HIV-1 RNA 3.0 ASSAY (BDNA)
Received Apr 16, 2009 · Event occurred Mar 31, 2009
Report 3003932969-2009-00004 · MDR key 1363190
Device
Generic name
Versant Hiv-1 Rna 3.0 Assay (bdna)
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
SYSTEM: Q340Catalog number
04589120
Lot number
REAGENTS: D070
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Exposure to Body Fluids
- Chemical Exposure
Narrative
Description of Event or Problem
A LABORATORY PROFESSIONAL REPORTED THAT ON (B)(6) 2009, SHE WAS DISCARDING SAMPLE WELLS AFTER COMPLETION OF AN (B)(6) ASSAY AND THINKS THAT FLUID FROM THE SAMPLE WELLS SPLASHED INTO HER EYE. THE OPERATOR WAS NOT FOLLOWING UNIVERSAL PRECAUTIONS, APPROPRIATE WARNINGS AND INSTRUCTIONS FOR USE. THERE HAS BEEN NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THIS INCIDENT.
Additional Manufacturer Narrative
CATALOG# 04484744. USER ERROR: THE INSTRUCTIONS FOR USE STATE THAT SAMPLES MAY BE INFECTIOUS AND THAT UNIVERSAL PRECAUTIONS SHOULD BE USED WHEN PERFORMING THE ASSAY. THE OPERATOR WAS WEARING GLOVES BUT WAS NOT WEARING SAFETY GLASSES. NO SPECIFIC TESTING WAS PERFORMED ON THE DEVICE WHICH WAS DISCARDED. THE LYSIS AND WASH STEPS IN THIS ASSAY SUBSTANTIALLY REDUCE THE POSSIBILITY OF HIV INFECTION. SUBSTRATE REAGENTS MAY CAUSE EYE IRRITATION. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.