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

Catalog Number	03337138001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for k, na, and cl results for 1 patient sample on a cobas b 221 blood gas analyzer.This medwatch will cover na.Refer to medwatch with a1 patient identifier (b)(6) for information on the cl results and medwatch with a1 patient identifier (b)(6) for information on the k results.The customer questioned the b 221 results as they did not match the patient's serum results from a c503 analyzer.The patient samples were reportedly collected and processed at the same time.The whole blood arterial sample on the b221 analyzer had a k result of 2.81 mmol/l, a na result of 129.7 mmol/l, and a cl result of 86.8 mmol/l.A serum sample from the patient was tested on a c503 analyzer and the k result was 4.1 mmol/l, a na result of 137.5 mmol/l, and a cl result of 99.0 mmol/l.The repeated results were deemed correct as the results correlated with the patient's clinical picture.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Sections d1, d2a, d2b, d4, g1 and g4 were updated.It was mentioned that the k electrode in-use time was expired.The in-use time for the na electrode was also expired.Using electrodes/consumables with an exceeded in-use time is considered as off-label use.Different samples and sample types were measured and different measurement methods were used.The c503 analyzer uses the indirect measurement method and the b221 analyzer uses the direct measurement method for ise tests.All of the alleged sample ise results on the b221 were determined to be below the corresponding reference ranges and were consistent with a pre-analytical sample-related issue.The investigation did not identify a product problem.The cause of the event was consistent with a preanalytic issue at the customer site.

• 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; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 20599113
• Report Number: 1823260-2024-03173
• Device Sequence Number: 8943594
• Product Code: CHL
• UDI-Device Identifier: 04015630018321
• UDI-Public: 04015630018321
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 01/08/2025

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: 03337138001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/08/2025
• 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