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

Catalog Number	04528778001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 111 analyzer serial number is (b)(6).The investigation included a review of the calibration and qc data; the calibration and qc results were within specifications.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable creatinine jaffe gen.2 (compensated) result from one patient sample tested on the cobas c 111 analyzer.The initial result was 3.7 mg/dl.The repeat result was 0.8 mg/dl.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The investigation included a review of the calibration and qc data: the calibration results were within the specified ranges.The qc results were within the specified ranges.A general reagent problem was ruled out because the calibration and qcs before the event were within the specified ranges.The customer replaced the photometer lamp, and no other issues were noted.Product labeling states, "replace photometer lamp utilities > maintenance > replace photometer lamp it is essential that the photometer lamp maintains a constant intensity in successive absorbance measurements.After a certain time of use, the intensity of the light emitted by the lamp deteriorates, and the accuracy of the measurements may no longer meet the required standards.Therefore, the lamp must be periodically replaced.The system alerts you when the lamp should be replaced by changing the maintenance action status to due (entry turns red)." the investigation determined the event was consistent with a user maintenance-related issue (photometer lamp maintenance).The investigation determined that the customer's action (photometer lamp replacement) resolved the issue.The investigation did not identify a product problem.

• 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 46250-0457
• MDR Report Key: 22587677
• Report Number: 1823260-2025-02273
• Device Sequence Number: 9340876
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 08/15/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 04528778001
• Device Lot Number: 83646301
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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