MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04745914001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable creatinine plus ver.2, sodium, and glucose assay results for 6 patient samples on a cobas 6000 c501 module.On (b)(6) 2026, sample 1 had an initial creatinine result of 7 mg/dl.The repeat result was 0.90 mg/dl.On (b)(6) 2026, sample 2 had an initial sodium result of 180.The repeat result was 139.On (b)(6) 2026, sample 3 had an initial glucose result of 18.The repeat result was 90.On (b)(6) 2026, sample 4 had an initial creatinine result of 7.92 mg/dl.The repeat result was 0.74 mg/dl.On (b)(6) 2026, sample 5 had an initial creatinine result of 1.62 mg/dl.The repeat result was 0.70 mg/dl.On (b)(6) 2026, sample 6 had an initial sodium result of 186.The repeat result was 135.The units of measurement for sodium and glucose were not provided.The date of event was set to the date the information was received by roche; the customer was unable to provide the exact date of event.
Additional Manufacturer Narrative
The creatinine reagent lot number is 934633.The expiration date was not provided.The sodium and glucose reagent information was not provided.The qc recovery data provided was within specification.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) found issues with the tubes at the washing unit and replaced them, performed decontamination of the washing unit, and replaced the reagent probe.The investigation determined that the issue found by the fse was the root cause of the event.

• Brand Name: COBAS 6000 C501 MODULE
• 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: 25219901
• Report Number: 1823260-2026-01970
• Device Sequence Number: 9801550
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060373
• 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): 06/15/2026

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/15/2026
• 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