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

Catalog Number	03337154001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Electrode lot numbers and expiration dates were requested, but not provided.The investigation is ongoing.Medwatch field d2b procode: product code chl applies to the pco2, po2, and ph parameters.Other product codes associated with the cobas b 221 <6> system are cem, cds, cga, ggf, ggz, ghs, gkr, jfp, jgs, khg, and khp.
Event or Problem Description
The initial reporter stated they received discrepant po2, pco2, chco3, be, and ph results for one patient sample tested on a cobas b 221 <6> system.The sample was initially tested and repeated on (b)(6) 2026, resulting in the following values: po2 = 159.3 mmhg with a data flag for the first value and 99.8 mmhg for the repeat value pco2 = 16.1 mmhg with a data flag for the first value and 30.2 mmhg with a data flag for the repeat value.Chco3 = 12.9 mmol/l for the first value and 20.6 mmol/l for the repeat value.Be = - 6.6 mmol/l for the first value and - 2.1 mmol/l for the repeat value.Ph = 7.522 with a data flag for the first value and 7.452 with a data flag for the repeat value.Testing for the sample was repeated on (b)(6) 2026 with a shorter delay between first and repeat measurements.The following values were obtained: po2 = 162.1 mmhg with a data flag for the first value and 156.4 mmhg with a data flag for the repeat value.Pco2 = 39.0 mmhg for the first value and 38.8 mmhg for the repeat value.Chco3 = 19.3 mmol/l for the first value and 19.0 mmol/l for the repeat value.Be = - 6.2 mmol/l for the first value and - 6.7 mmol/l for the repeat value.Ph = 7.313 with a data flag for the first value and 7.308 with a data flag for the repeat value.
Additional Manufacturer Narrative
The investigation determined the issue is consistent with insufficient pre-analytic sample handling.The investigation did not identify a product problem.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24728310
• Report Number: 1823260-2026-01157
• Device Sequence Number: 18452296
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 05/11/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/11/2026
• 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