MAUDE Adverse Event Report: Roche Diagnostics cobas 6000 c501 module; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04745914001
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	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tina-quant albumin gen.2 - urine application results for 1 patient on a cobas 6000 c501 module.The initial result was 52.5 mg/l.The repeat result was 7.7 mg/l.Additional repeat results were 31.6 mg/l and 7.5 mg/l.The results on a cobas c311 on (b)(6) 2026 were 10.8 mg/l and 5.8 mg/l.The results on the c501 on (b)(6) 2026 were 6.8 mg/l and 7.1 mg/l.A precision test was performed with the original sample, yielding the following results: 25.9 mg/l, 44.8 mg/l, 41.0 mg/l, 17.2 mg/l, 13.9 mg/l.
Additional Manufacturer Narrative
The tina-quant albumin gen.2 - urine application reagent lot number is 926603, and the expiration date was not provided.A field service engineer (fse) replaced the rinse unit tubing, reagent nozzles, and a reagent valve.The fse thoroughly checked and cleaned all fluidic and vacuum lines,¿ including the tank.Qc recovery was within specifications after these actions.The investigation is ongoing.

• Brand Name: cobas 6000 c501 module
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50870263
• Report Number: 1823260-2026-03904
• Device Sequence Number: 21511828
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/23/2026

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: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• 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