APTIMA COMBO 2 ASSAY
Received Oct 17, 2014 · Event occurred Sep 18, 2014
Report 2024800-2014-00003 · MDR key 4182416
Device
Generic name
In-vitro Diagnostic Assay
Manufacturer
Hologic IncorporatedCatalog number
301040-01
Lot number
108724A
Product problems
- Burst Container or Vessel
- Improper or Incorrect Procedure or Method
Patient
25 YR
- Exposure to Body Fluids
Narrative
Description of Event or Problem
THE LAB TECH REPORTED THAT SHE SPLASHED SOLUTION CONTAINED IN THE APTIMA COMBO 2 URINE SPECIMEN COLLECTION TUBE INTO HER EYES. AS SHE WAS PIPETTING THE URINE INTO THE SPECIMEN COLLECTION TUBE WITH THE PROVIDED PIPET, THE TRANSPORT MEDIA RAISED AND BUBBLED UP AND A BUBBLE POPPED CLOSE TO HER FACE. IT WAS NOTED THAT SHE IS SHORT IN STATURE AND THEREFORE WAS CLOSE TO THE TUBE. THE LAB TECH WAS NOT WEARING GOGGLES AS IS REQUIRED BY INSTRUCTION IN THE PACKAGE INSERT FOR THE APTIMA COMBO 2 URINE SPECIMEN COLLECTION KIT, BUT WAS WEARING GLOVES AND A LAB COAT. AFTER THE EVENT, THE LAB TECH FLUSHED HER EYES WITH WATER AND WENT TO THE ER AND WAS PRESCRIBED ANTIBIOTICS. ACCORDING TO THE SAFETY DATA SHEET FOR THE APTIMA COMBO 2 URINE SPECIMEN COLLECTION KIT, THE SOLUTION IS NOT CONSIDERED HAZARDOUS BY THE 2012 OSHA HAZARD COMMUNICATION STANDARD (29 CFR 1910.1200).