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

Catalog Number	04528778001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of a discrepant high result for 1 patient sample tested for creatinine jaffe on a cobas c 111 analyzer.The initial result was 3.47 mg/dl.The repeat result was 0.67 mg/dl.
Additional Manufacturer Narrative
The reagent lot number and expiration date were not provided.
Additional Manufacturer Narrative
The investigation included a review of the data set provided by the customer: the calibration and qc results were within the specified ranges.The instrument data did not indicate any product issues.The field service engineer (fse) performed a comprehensive technical evaluation of the analyzer.Functional testing was conducted on critical subsystems, including pipetting accuracy, thermal stability, probe washing efficiency, photometer performance, needle detection, and homogenization, with all components found to be operating within manufacturer specifications.To validate system performance, successful comprehensive mechanical checks and an assay precision check using qc were performed.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 23759597
• Report Number: 1823260-2025-05019
• Device Sequence Number: 21352232
• 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): 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): 01/21/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/21/2026
• 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