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	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with creatinine plus ver.2 assay and 1 patient sample tested with uric acid assay on a cobas c 111 analyzer.Patient 1 tested for creatinine: initial result: 1.82 mg/dl.Repeat result: 39.98 mg/dl.Patient 2 tested for uric acid: initial result: 0.64 mg/dl accompanied by a qc alarm.Repeat result: 6.56 mg/dl.The initial results did not match the patients' history, and the samples were repeated on (b)(6) 2025.The repeat results were deemed to be correct as they matched the patients' previous results.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
The creatinine reagent lot number was 84198801 with an expiration date of 31-jul-2025.The uric acid reagent lot number and expiration date were not provided.The field service engineer replaced the syringe seal and cleaned the reaction rotor.The investigation is ongoing.
Additional Manufacturer Narrative
The maintenance was up to date, and the extra wash cycles were correctly installed.The qc did not show any systemic issue with either the instrument or the reagents.Alarms of sample pipetting and failed to aspirate sample from tube were detected.These alarms are a strong indicator of poor sample quality.The investigation did not identify a product problem.The cause of the event was consistent with improper tube placement, insufficient volume, and/or bubbles in the sample.

• 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: 22055083
• Report Number: 1823260-2025-01557
• Device Sequence Number: 4171074
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 10/15/2025

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 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: 04/24/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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 Age: 77 YR
• Patient Sex: Female