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

Catalog Number	04528778001
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	11/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tina-quant albumin gen.2 results from the cobas c 111 analyzer for nine patients.Patient (b)(6) initial result was 102.25 mg/l.The repeat result on 10-nov-2025, from another laboratory, was 58.7 mg/l.Patient (b)(6) initial result was 28.91 mg/l.The repeat result from another laboratory was 20.7 mg/l.Patient (b)(6) initial result was 34.95 mg/l.The repeat result from another laboratory was 21.1 mg/l.Patient (b)(6) initial result was 55.1 mg/l.The repeat result from another laboratory was 27.5 mg/l.Patient (b)(6) initial result was 237.5 mg/l.The repeat result from another laboratory was 343 mg/l.Patient (b)(6)initial result was 84.3 mg/l.The repeat result from another laboratory was less than 2.50 mg/l.Patient (b)(6) initial result was 50.7 mg/l.The repeat result from another laboratory was 3.01 mg/l.Patient (b)(6) initial result was 19.5 mg/l.The repeat result from another laboratory was 8.62 mg/l.Patient (b)(6) initial result was 22.4 mg/l.The repeat result from another laboratory was 10 mg/l.
Additional Manufacturer Narrative
The cobas c 111 analyzer serial number is (b)(6).Calibration and qc were passing at the time of the event.The investigation is ongoing.
Additional Manufacturer Narrative
The medwatch section d, device identification was updated.Relevant fields of sections d and g were updated.The investigation was unable to determine a direct root cause.The most likely root cause identified was pre-analytical handling, specifically the lack of urine sample centrifugation, which is consistent with the presence of precipitates and inconsistent results.There was no evidence of an instrument or reagent product issue found.

• 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: 23706717
• Report Number: 1823260-2025-04928
• Device Sequence Number: 10691701
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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
• Device Lot Number: 85897401
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/23/2026
• 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