MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 6 SYSTEM; BLOOD GAS ANALYZER

Catalog Number	03337154001
Medical Device Problem Codes	Computer Software Problem (1112); Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was advised to make sure qc lock and "check 2sd range" settings were switched on, then perform a controlled shutdown of the systems to ensure the settings are locked in.The investigation is ongoing.
Event or Problem Description
The initial reporter stated there was a software issue with four of their cobas b 221 6 systems.The specific date of the event is not known.The customer alleges that internal quality control locks set up for the po2, cl, glucose, and lactose assays were deactivated.This allows patient measurements to be completed while internal controls are outside of range.The customer believes the issue occurred "a number of months ago", but was only noted once internal controls were unacceptable.There was no allegation of discrepant patient results due to the issue.A serial number of (b)(6) was provided for one of the affected systems.The serial numbers of the other three systems were requested, but not provided.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect settings made by the user.

• Brand Name: COBAS B 221 6 SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19332291
• Report Number: 1823260-2024-01469
• Device Sequence Number: 7009788
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K032311
• 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,Followup
• Report Date (Section B): 05/29/2024

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: 03337154001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 05/29/2024
• 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
• Patient Sex: Unknown