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

Catalog Number	03337154001
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a software issue with a cobas b 221 system.After replacing the hard drive on the instrument, the parameters were incorrectly configured from a sample type of "blood" to the sample type of "aqueous solution." the customer reconfigured the parameters back to the correct setting ("blood" sample type), performed a controlled instrument shutdown, and rebooted the system.After rebooting the system, the settings reverted back to "aqueous solution" as the sample type instead of saving the correct setting ("blood" sample type).The customer attempted to reset the instrument 2 more times but the issue was not resolved.
Additional Manufacturer Narrative
An evaluation of the provided instrument data showed that all measurements were performed with an aqueous sample type on (b)(6) 2023.The field service engineer replaced the solid-state drive (ssd) of the analyzer.No further issues occurred after the ssd replacement.The investigation determined the issue was resolved by the ssd replacement.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17061051
• Report Number: 1823260-2023-01839
• Device Sequence Number: 5130532
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): N
• 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): 08/29/2023

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): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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