MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® HPV; KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Catalog Number	09040544190
Medical Device Problem Codes	Device Emits Odor (1425); Use of Device Problem (1670)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The serial number of the cobas 5800 was (b)(6).It was indicated that the approximate size of the laboratory room is 10 square meters.According to the operator, there is no ventilation in the room and no air exchange.After the incident, a ventilation system was installed in the laboratory.However, the engineer who inspected the analyzer and the room, concluded that this ventilation was insufficient.Per the safety data sheets of the cobas hpv assay as well as the user assistance of the cobas 5800 instrument, the need for sufficient ventilation (air exchange) is described; "provide sufficient air exchange and/or exhaust in work rooms." the investigation determined that the root cause has been identified to be operating in a small room without sufficient air exchange.
Event or Problem Description
The initial reporter alleged that during the use of the cobas 5800 instrument experienced a chemical burn to the upper respiratory tract.It was alleged to have occurred during an hpv run where a sharp unpleasant odor emanated from the device.The operator allegedly sought medical support and went to the hospital and was diagnosed with a chemical burn of the upper respiratory tract.It is unknown what kind of medical treatment was provided.Allegedly, before the incident the operator had no health problems.Although multiple attempts were made, no additional information on the operator's status could be provided.

• Brand Name: COBAS® HPV
• Common Device Name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
• 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 ; 9253534412
• MDR Report Key: 20762087
• Report Number: 2243471-2024-03401
• Device Sequence Number: 8587873
• Product Code: MAQ
• UDI-Device Identifier: 00875197006889
• UDI-Public: 00875197006889
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: P190028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: 09040544190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/22/2024
• 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