ULTRIO PLUS
Received Nov 26, 2014 · Event occurred Oct 19, 2014
Report 2024800-2014-00005 · MDR key 4281158
Device
Generic name
In Vitro Diagnostic Assay
Manufacturer
Hologic IncorporatedCatalog number
302573
Lot number
ML 635124
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Injury
Narrative
Additional Manufacturer Narrative
THE EVENT OCCURRED WHILE THE OPERATOR WAS REMOVING WASTE BAGS FROM THE TIGRIS INSTRUMENT AFTER RUNNING ULTRIO PLUS ASSAYS ((B)(4)). ALTHOUGH THE PERFORMANCE OF THE ASSAY IS NOT IN QUESTION, HOLOGIC IS INVESTIGATING THE OCCURRENCE FURTHER TO DETERMINE IF THERE IS SOMETHING THE OPERATOR DID THAT CONTRIBUTED TO THE EVENT AND/OR IF THE WASTE BAGS SOMEHOW CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WILL BE PROVIDED WHEN AVAILABLE.
Description of Event or Problem
A (B)(6) OPERATOR IN (B)(6) WAS INJURED ON THE RIGHT HAND WITH A TIP DURING THE EMPTYING OF A TIGRIS WASTE (DITI BAG) BAG. THE OPERATOR DISINFECTED THE INJURY AND VISITED THE ON-SITE DOCTOR WHO GAVE HER A POST EXPOSURE PROPHYLAXIS. THE OPERATOR, 10 DAYS AFTER THE INCIDENT, DID ALL THE TESTS REQUIRED TO VERIFY A POSSIBLE INFECTION; SO FAR, EVERYTHING RESULTED NEGATIVE.