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

Catalog Number	04528778001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ca2 reagent lot number was 88542701 with an expiration date of 31-aug-2026.It was found that the halogen lamp was burned out, and the water filter was dirty, as the water tank had never been cleaned.The water filter was last replaced in (b)(6) 2025.The customer replaced the halogen lamp with a used lamp in better condition, cleaned the water tank and filter, decontaminated the sample probe, and calibration and qc were acceptable.Qc material was used for precision testing, and the results were acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of discrepant results for 2 patient samples tested for calcium gen.2 (ca2) on a cobas c 111 analyzer.Patient 1 initial ca2 result was 10.87 mg/dl.The sample was repeated twice, with results of 14.2 mg/dl and 10.09 mg/dl.On (b)(6) 2026, patient 2 initial ca2 result was 14.8 mg/dl.The repeat result was 9.65 mg/dl.

• 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: 24367591
• Report Number: 1823260-2026-00551
• Device Sequence Number: 9661040
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 06/15/2026

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): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 06/15/2026
• 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