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

Catalog Number	03337154001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient tested for pco2, ph, and sodium (na) on a cobas b 221 6 system compared to a competitor system.The pco2 result from the b221 system was 76.2 mmhg.The pco2 result from the competitor system was 52.8 mmhg.The ph result from the b221 system was 7.176.The ph result from the competitor system was 7.346.The na result from the b221 system was 133.7 mmol/l.The na result from the competitor system was 142 mmol/l.
Additional Manufacturer Narrative
No electrode lot numbers with expiration dates were provided.The competitor system is the abl 800 flex.Qc was acceptable.
Additional Manufacturer Narrative
The results from the b221 and competitor systems were from 2 different venous samples.There were 20 minutes between the results from each system.The relevant electrodes were requested for investigation, however, they were not provided.No relevant error messages were observed to have occurred around the time of the event.Calibration and qc were acceptable.No issues were identified when reviewing the instrument signal data.Based on the data provided, the investigation determined the event was consistent with a preanalytical handling issue.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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19061509
• Report Number: 1823260-2024-01068
• Device Sequence Number: 20483769
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 07/16/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/16/2024
• 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