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

Catalog Number	03337154001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode lot numbers with expiration dates were not provided.Qc was acceptable.On 23-feb-2024 the field service representative (fsr) found an issue with the fluid pack and replaced it.Calibration was acceptable.Samples were tested on both b221 systems and the results were acceptable.On 26-feb-2024 the fsr returned to the customer site due to an instrument error message and replaced the electrodes.Calibration and qc were acceptable.Samples were tested on both b221 systems and the results were acceptable.The customer has had no further issues.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned the results for an unspecified number of patient samples tested on a cobas b 221 6 system.Discrepant results were provided for 2 patient samples tested for sodium (na+) and calcium (ca+).Patient 1 initial na+ result was 167.2 mmol/l.The result from a different b 221 system was 156.3 mmol/l.Patient 2 initial ca+ result was 4.06 mg/dl.The result from a different b 221 system was 4.96 mg/dl.The questionable results were not reported to the patients.
Additional Manufacturer Narrative
No instrument data was provided from the day of the event.Based on the information provided, the cause of the event could not be determined.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: 18904160
• Report Number: 1823260-2024-00760
• Device Sequence Number: 7919413
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): Y
• Initial Reporter Country: AR
• 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): 04/15/2024

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: 02/21/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/15/2024
• 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