MAUDE Adverse Event Report: ROCHE DIAGNOSTICS OMNI; BLOOD GAS ANALYZER

Catalog Number	03337111001
Medical Device Problem Codes	Suction Problem (2170); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation is field service engineer/company representative.The fse removed the burnt tube and performed instrument maintenance.The burnt tube was requested for investigation.
Event or Problem Description
The initial reporter complained of auto qc (aqc) errors on a cobas b221 system.The customer opened the aqc drawer and observed that the motor was not in the correct position and would not move when programmed to move.The qc mechanism was stuck and would not release.The field service engineer (fse) visited the customer site and found a burnt tube.No one was injured by the burnt tube and no questionable results were generated due to the issue.
Additional Manufacturer Narrative
The auto qc error issue was resolved by replacing the burnt tube.The burnt tube was requested for investigation, however, it could not be provided as it has been discarded.As the product was not available to investigate, the cause of the burnt tube could not be determined.

• Brand Name: OMNI
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12382784
• Report Number: 1823260-2021-02510
• Device Sequence Number: 4648689
• Product Code: CHL
• UDI-Device Identifier: 04015630018307
• UDI-Public: 04015630018307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K945915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03337111001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1