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

Catalog Number	04528778001
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable triglycerides, bilirubin total gen.3, uric acid ver.2, and calcium gen.2 results for 2 patient samples on a cobas c 111 analyzer module.On (b)(6) 2025, patient 1 had an initial total bilirubin result of 19.4 umol/l and a triglycerides result of 4.61 mmol/l from another laboratory.The sample was repeated on the customer's c111 analyzer and the total bilirubin result was 14.3 umol/l and the triglycerides result was 3.15 mmol/l.On (b)(6) 2025, a sample for patient 2 was repeated 8 times on the c111 analyzer.On (b)(6) 2025, the sample had total bilirubin results of 29.8 umol/l, 28.8 umol/l, 28.8 umol/l, and 29.3 umol/l.On (b)(6), the sample had results of 37.8 umol/l, 35.4 umol/l, 35.4 umol/l, and 35.4 umol/l.On (b)(6) 2025, the sample had uric acid results of 278.0 umol/l, 279.3 umol/l, 282.8 umol/l, and 281.7 umol/l.On (b)(6), the sample had results of 365.2 umol/l, 337.3 umol/l, 356.7 umol/l, and 348.4 umol/l.On (b)(6), the sample had calcium results of 2.29 mmol/l, 2.32 mmol/l, 2.32 mmol/l, and 2.32 mmol/l.On (b)(6), the sample had results of 2.92 mmol/l, 2.71 mmol/l, 2.83 mmol/l, and 2.83 mmol/l.
Additional Manufacturer Narrative
The reagent lot numbers and expiration dates were not provided.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) found that the end of the probe was yellow and replaced it along with the seal cap, teflon seal, and fluid filter.Qc was performed successfully.The service maintenance actions performed by the fse resolved the issue.

• 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: 22795434
• Report Number: 1823260-2025-02471
• Device Sequence Number: 8511755
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/10/2025
• 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