MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® 6800 SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Catalog Number	05524245001
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A field service representative (fsr) was allegedly at a customer site for a repair of the solid waste locking system on the cobas 6800 instrument.The fsr was reportedly disposing of the liquid waste without proper eye protection when some splashed into his eyes.The fsr reportedly went to see an optometrist and an eye doctor.The optometrist took a retinal photo and measured the pressure on both eyes.The retina is ok.The doctor prescribed painkillers and antibiotics.It was reported that his right eye is better and the left eye is still giving pain and swelling but less than before.
Additional Manufacturer Narrative
The fsr was reportedly wearing personal prescriptive glasses but not proper eye protection.Per the cobas 6800 instrument safety guide, it is important to "wear appropriate personal protective equipment, including eye protection" when working with the instrument.

• Brand Name: COBAS® 6800 SYSTEM
• Common Device Name: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876
• MDR Report Key: 19127881
• Report Number: 2243471-2024-01193
• Device Sequence Number: 18049608
• Product Code: MZA
• UDI-Device Identifier: 04015630935406
• UDI-Public: 04015630935406
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: BK140196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 05524245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown