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

Catalog Number	03337154001
Medical Device Problem Codes	Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for sodium electrode (na) and chloride electrode (cl) on a cobas c 303 analytical unit and a cobas b 221 <6> system.This medwatch will cover the results from the b221 system.Refer to medwatch with a1 patient identifier (b)(6) for information on the results from the c303 analyzer.For na: the avl system result was 134 mmol/l.The c303 analyzer result was 134 mmol/l.The b221 result was 137.5 mmol/l.The hibrid system result was 143 mmol/l.The c303 analyzer result and the hibrid system results are discrepant.For cl: the c303 analyzer result was 105 mmol/l.The b221 result was 103.7 mmol/l.The hibrid system result was 115 mmol/l.The b221 system and the hibrid system results are discrepant.
Additional Manufacturer Narrative
No electrode lot numbers with expiration dates were provided.
Additional Manufacturer Narrative
It was clarified that the "hibrid" system was the same c303 analyzer.The initial report stated: for na: the avl system result was 134 mmol/l.The c303 analyzer result was 134 mmol/l.The b221 result was 137.5 mmol/l.The hibrid system result was 143 mmol/l.The c303 analyzer result and the hibrid system results are discrepant.For cl: the c303 analyzer result was 105 mmol/l.The b221 result was 103.7 mmol/l.The hibrid system result was 115 mmol/l.The b221 system and the hibrid system results are discrepant.This should read: for na: the avl system result was 134 mmol/l.The c303 analyzer result was 134 mmol/l.The b221 result was 137.5 mmol/l.The c303 analyzer result was 143 mmol/l.For cl: the c303 analyzer result was 105 mmol/l.The b221 result was 103.7 mmol/l.The c303 analyzer system result was 115 mmol/l.The high results from the c303 analyzer are in question.The results from the avl system and the b221 system were believed to be correct.The field application specialist (fas) and field service engineer (fse) visited the customer site.The dilution vessel and sippers were cleaned.The daily green rack was run, ise checks and reagent purges were performed, and calibration and qc were completed with no issues.The high results were consistent with an improperly emptying/drying of the mixing vessel caused by contamination of the dilution vessels or clogged vacuum nozzles.This contamination is due to poor sample quality.The investigation determined the event was due to a preanalytical handling issue.

• 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: 22839419
• Report Number: 1823260-2025-02543
• Device Sequence Number: 4902744
• Product Code: CEM
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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): 09/17/2025

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: 07/22/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/17/2025
• 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 Age: 35 YR
• Patient Sex: Male