MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 4000 C311 STAND ALONE SYSTEM; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04826876001
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	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable creatinine and ise indirect na-k-cl for gen.2 results for 5 patient samples on a cobas 4000 c311 stand alone system.Sample 1 had an initial na result of 122 mmol/l with a data flag, an initial k result of 4.15 mmol/l, and an initial cl result of 85.3 mmol/l.The repeat na result was 150 mmol/l with a data flag, the repeat k result was 5.37 mmol/l, and the repeat cl result was 111.7 mmol/l with a data flag.Sample 2 had an initial creatinine result of 27 umol/l with a data flag.The repeat result was 80 umol/l.Sample 3 had an initial na result of 161 mmol/l with a data flag, an initial k result of 6.23 mmol/l with a data flag, and an initial cl result of 129.3 mmol/l with a data flag.The repeat na result was 141 mmol/l, the repeat k result was 4.74 mmol/l, and the repeat cl result was 109.9 mmol/l with a data flag.Sample 4 had an initial creatinine result of 38 umol/l with a data flag.The repeat result was 91 umol/l.Sample 5 had an initial creatinine result of 29 umol/l with a data flag.The repeat result was 95 umol/l.
Additional Manufacturer Narrative
The reagent and electrode information were not provided.The field service engineer (fse) found that the rinse arm assembly was not functioning correctly.The fse adjusted the overfilling rinse unit and corrected the placement of the detergent bottle, which had been incorrectly positioned.The service maintenance actions performed by the fse resolved the issue.

• Brand Name: COBAS 4000 C311 STAND ALONE SYSTEM
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23816773
• Report Number: 1823260-2025-05135
• Device Sequence Number: 21325637
• Product Code: JJE
• UDI-Device Identifier: 04015630925551
• UDI-Public: 04015630925551
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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: 04826876001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/16/2025
• 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