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

Catalog Number	03337154001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bilirubin electrode lot number and expiration date were not provided.
Event or Problem Description
There was an allegation of discrepant results for 1 patient tested for bilirubin on a cobas b 221 6 system compared to a cobas c 503 analytical unit.The result from the c503 analyzer was 18.6 mg/dl.This result was believed to be correct as it corresponded to the patient¿s clinical picture.The result from the b221 analyzer was 30.7 mg/dl.Due to this high result, a new sample was obtained and the result from the b221 analyzer was 25.0 mg/dl.
Additional Manufacturer Narrative
The customer did not provide the log files from the date of the event.The customer has had no further issues.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: 19182404
• Report Number: 1823260-2024-01277
• Device Sequence Number: 7412419
• 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): 06/10/2024

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): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/10/2024
• 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: 5 DA
• Patient Sex: Unknown