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	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned high results for an unspecified number of patient samples tested for potassium electrode (k+) on a cobas b 221 6 system.Examples of discrepant results were provided for 2 patient samples.On (b)(6) 2023 patient b initial result from an arterial sample was 10.20 mmol/l.The result from a venous sample was 3.13 mmol/l.As these are different sample types, the results for patient b may be from different samples.On (b)(6) 2023 patient a initial result from a venous sample on a different b221 system was 2.88 mmol/l.The result from the b221 system in question from an unknown sample type was 4.29 mmol/l.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
On (b)(6) 2023 the customer replaced the fill port and the tubing on the instrument.The turn & dock (t&d) was washed and cleaned as the customer suspected the samples were hemolyzed when they were injected causing an obstruction.Successful qc was performed afterward.The instrument was calibrated and "several" samples were processed with no issues; the results were comparable to other instruments.The customer stated the issue was resolved by the maintenance they performed.The investigation determined the k+ electrode (lot#21520369 sn (b)(6)) was installed on (b)(6) 2022.The k electrode has a maximum in-use time of 23 weeks and should not have been used after (b)(6) 2022.The reference electrode (lot#21520750 sn (b)(6)) had an install before date of (b)(6) 2022.The reference electrode has a maximum in-use time of 52 weeks and should not have been used after (b)(6) 2023.The sensor contact electrode (lot#21583447 sn (b)(6)) had an install before date of (b)(6) 2020.The sensor contact electrode has a maximum in-use time of 156 weeks and should not have been used after (b)(6) 2023.As all qc performed was successful, the parts replaced by the customer are not suspected to be the cause of the issue.It is not known when the parts were initially installed.No instrument data was provided for investigation.Based on the information provided, the specific cause of the event could not be determined.Based on the results provided, the issue is consistent with a preanalytical handling issue.
Additional Manufacturer Narrative
The investigation findings and investigation conclusion codes were updated.

• 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: 18148728
• Report Number: 1823260-2023-03625
• Device Sequence Number: 6988589
• 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): 11/22/2023

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: 10/20/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 11/22/2023
• 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