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

Catalog Number	05524245001
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was reportedly wearing gloves.The customer was reportedly following a user assistance troubleshooting article and was unable to recall which one.The investigation confirmed the metal edge of the reagent storage air exhaust on the customer¿s instrument is within specifications.No parts were repaired or replaced as there was no evidence of a product malfunction.The user assistance of the cobas 6800 instrument includes several warnings indicating "risk of hand injury due to sharp edges inside the system.Do not reach inside the system.".
Event or Problem Description
We received information that a customer cut his outer right thumb on the cobas 6800 reagent storage air exhaust.The customer reportedly applied a bandaid on the wound and received a tetanus shot from the hospital employee health facility.No additional treatment was required.

• 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: 18266859
• Report Number: 2243471-2023-03859
• Device Sequence Number: 7840535
• Product Code: MZA
• UDI-Device Identifier: 04015630935406
• UDI-Public: 04015630935406
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/05/2023
• 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