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	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The k electrode lot number and expiration date were requested, but not provided.The field service engineer replaced the main peristaltic pump tubing.The entry port and needle were also replaced.Internal and external cleaning was carried out.The calcium electrode was changed.System calibrations and quality controls were run; all were ok.Patient samples were processed on the system and repeated on another system; the results matched.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the k electrode on a cobas b 221 6 system.The customer stated that the k electrode and reference electrode were changed.Calibration and controls were within range.The customer then noticed high k results.The whole blood samples of the patients are initially tested.These samples are centrifuged and the plasma is then tested.For the first patient sample, the whole blood resulted in a k value of 6.94 mmol/l.The plasma resulted in a k value of 4.54 mmol/l.The plasma was also tested on a second cobas b 221 system, resulting in a k value of 4.46 mmol/l.For the second patient sample, the whole blood resulted in a k value of 5.57 mmol/l.The plasma resulted in a k value of 3.42 mmol/l.The plasma was also tested on a second cobas b 221 system, resulting in a k value of 3.41 mmol/l.
Additional Manufacturer Narrative
The investigation determined the issue is consistent with insufficient pre-analytic sample handling and/or the sample material itself.The investigation did not identify a product 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20217112
• Report Number: 1823260-2024-02668
• Device Sequence Number: 7202736
• 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): 12/10/2024

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: 08/26/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 12/10/2024
• 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 Sex: Unknown