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

Catalog Number	04777433001
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	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c111 analyzer serial number was (b)(6).The bilt3 reagent lot number used on the cobas 8000 system was 810295 with an expiration date of 31-jan-2026.The field service engineer (fse) cleaned the photometer, lens, and rotor.The fse checked various instrument parts and cleaned the water filter and purged the fluid system.Qc was performed.Patient samples were run and repeated for bilt3 and bild2 with acceptable results.The issue was not resolved.The fse returned to the customer site and decontaminated the fluid system and replaced the sample probe, and the photometer.A pipetting accuracy check was completed along with qc and patient sample monitoring.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 2 samples from 1 patient tested for bilirubin total gen.3 (bilt3) on a cobas c 111 analyzer with ise.Sample 1: the initial result from the (b)(6) analyzer was 0.10 mg/dl.The sample was repeated twice with results of 0.02 mg/dl and [-] 0.00 mg/dl with an invalidating data flag.The sample was repeated on a cobas 8000 system with a result of 0.09 mg/dl.Sample 2: the initial result from the (b)(6) analyzer was 0.38 mg/dl.The sample was repeated twice with results of 0.50 mg/dl and 0.38 mg/dl.The sample was repeated on a cobas 8000 system with a result of 0.36 mg/dl.
Additional Manufacturer Narrative
Section d, device identification, was updated.Relevant fields of sections d and g were updated.The bilt3 reagent lot number was 815904 with an expiration date of 28-feb-2026.Over the course of multiple service visits, the following actions were performed by the field service engineer (fse): cleaned the 250 l syringe and replaced the teflon seal, cleaned the syringe linear guide, checked temperatures and fans, cleaned the photometer, lens, and rotor, checked the halogen lamp, sample syringe tip, and reagent, adjusted the sample probe, cleaned the water filter and gallon, and purged the fluid system, replaced the sample probe and the photometer, performed photometer initialization and air/water calibration, and checked pipetting accuracy.Afterward, the customer monitored patient samples.The customer stated the instrument was operating normally.The investigation determined that the service actions resolved the issue.As several service actions were performed, the specific cause of the event could not be determined.

• Brand Name: COBAS C 111 ANALYZER WITH ISE
• 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: 22784738
• Report Number: 1823260-2025-02449
• Device Sequence Number: 8256605
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K071211
• 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): 09/05/2025

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: 02/28/2026
• Device Catalogue Number: 04777433001
• Device Lot Number: 815904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/05/2025
• 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: Female