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	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The creaj2 reagent lot number was 80201801 with an expiration date of 28-feb-2026.The chol2 reagent lot number was 84696601 with an expiration date of 31-aug-2025.The customer stated that they had lamp alarms (unstable photometer failures) and liquid level detection alarms.The field service engineer checked the instrument for the liquid level detection alarms.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with creatinine jaff gen.2 (creaj2) assay and cholesterol gen.2 (chol2) assay on a cobas c 111 analyzer.Creaj2: initial result: 3.800 mg/dl.Repeat result: 0.700 mg/dl.Chol2: initial result: 359.6 mg/dl.Repeat result: 196.81 mg/dl.During the validation process, the customer questioned the initial results as they were high.No questionable results were reported outside the laboratory, and the sample was then repeated.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
Data was requested to conduct an investigation but was not provided.The customer stopped using the instrument.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: 22540471
• Report Number: 1823260-2025-02188
• Device Sequence Number: 8614655
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 09/05/2025

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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/05/2025
• 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