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	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with creatinine plus ver.2 on a cobas c 111 analyzer.The first sample initially resulted in a creatinine value of 1.05 mg/dl and it repeated as 0.69 mg/dl.The second sample initially resulted in a creatinine value of 1.14 mg/dl and 0.86 mg/dl on (b)(6) 2026.The customer cleaned the probe, performed washing maintenance, and changed the water.The customer then repeated the sample again, resulting in creatinine values of 1.07 mg/dl and 0.82 mg/dl.The sample was repeated on a fuji dry-chem xn700 analyzer, resulting in a creatinine value of 0.61 mg/dl.The third sample initially resulted in a creatinine value of 1.42 mg/dl and 1.09 mg/dl on (b)(6) 2026.The customer cleaned the probe, performed washing maintenance, and changed the water.The customer then repeated the sample again, resulting in creatinine values of 1.18 mg/dl and 1.01 mg/dl.The sample was repeated on a fuji dry-chem xn700 analyzer, resulting in a creatinine value of 0.86 mg/dl.
Additional Manufacturer Narrative
The serial number of the c 111 analyzer is (b)(6).The investigation is ongoing.Medwatch field e1 initial reporter establishment name - (b)(6).

• 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: 25003154
• Report Number: 1823260-2026-01657
• Device Sequence Number: 15905958
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 05/19/2026

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 Expiration Date: 04/24/2026
• Device Catalogue Number: 04528778001
• Device Lot Number: 91676101
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/19/2026
• 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