MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 <4> SYSTEM; BLOOD GAS ANALYZER

Model Number	B221
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned high potassium (k) results for 5 patients tested on two cobas b 221 systems.The customer is questioning the results from whole blood samples run on the b 221 instruments compared to results from plasma samples run on non-roche instruments in the hospital laboratory.Arterial blood samples were obtained from the arterial line for running on the b 221 instruments.Due to the high k results, plasma samples were drawn and sent to the laboratory where the results were "normal." refer to the attached data for the patient results.No questionable results were reported outside of the laboratory.The customer used the results from the laboratory to monitor the patient¿s condition.The k electrode lot number was 21523447.The expiration date was not provided.The electrode was installed in aug-2022.
Additional Manufacturer Narrative
Calibration and 3 levels of qc were acceptable.It was noted that the customer ran the whole blood samples on both b 221 instruments and the results were comparable to one another.Preventive maintenance was last performed in dec-2022.On 10-feb-2023, the k electrode and the reference electrode were replaced.The investigation is ongoing.
Additional Manufacturer Narrative
The k electrode lot number was initially provided as "21523447." the k electrode lot number should be 21522447.The investigation did not identify any relevant instrument errors around the time of the questionable results.The k electrode and reference electrode were received for investigation.The electrodes showed no signs of damage.No electrode issues were identified.Testing was performed using blood samples at the investigation site.All results were consistent except for the last sample that was run.For this last sample, a high k result was obtained and a low result was obtained for the calcium (ca) parameter.This result constellation indicates hemolysis.Testing at the investigation site was performed with whole blood samples.The k results were consistent and no discrepant results were obtained.Based on the instrument data, the instrument measured the high k results correctly.The customer used "syringe injection mode." after the customer replaced the fill port and the needle, no more issues were observed.The investigation determined the issue at the customer site was consistent with a partially blocked sample path.The presence of small clots in the sample would cause hemolysis of the sample.Hemolysis can lead to increased levels of potassium.The investigation was unable to reproduce the customer's observation.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• Brand Name: COBAS B 221 <4> SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16463803
• Report Number: 1823260-2023-00628
• Device Sequence Number: 14076802
• Product Code: CHL
• UDI-Device Identifier: 04015630018321
• UDI-Public: 04015630018321
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 05/03/2023

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 Model Number: B221
• Device Catalogue Number: 03337138001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 05/03/2023
• 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