MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 111 ANALYZER; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04528778001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The creatinine jaffe gen.2 (compensated) reagent lot number is 83646301, and the expiration date is 30-jun-2026.A field service engineer (fse) determined that the syringe seal was worn out and replaced it and cleaned the water container.The controls were approved following the maintenance.The investigation determined that the service action resolved the issue.
Event or Problem Description
There was an allegation of questionable creatinine jaffe gen.2 (compensated) results from the cobas c 111 analyzer.Patient 1's initial result was 3.64 mg/dl, and the repeat result was 0.65 mg/dl.The doctor questioned the initial result as it did not match the patient's clinical condition.The repeat result was deemed to be correct.Patient 2's initial result on (b)(6) 2025 was 3.91 mg/dl, and the repeat result was 0.94 mg/dl.The repeat result was deemed to be correct.The initial result was not released outside of the laboratory.

• Brand Name: COBAS C 111 ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22165972
• Report Number: 1823260-2025-01766
• Device Sequence Number: 13066046
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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: 04528778001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 06/09/2025
• 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: Female