MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05860636001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for four patient samples tested with the sodium electrode on a cobas 6000 c (501) module.The customer stated that controls run for sodium were outside of range, so they repeated patient samples that were tested prior to the outage.The samples were repeated on a second analyzer and of these, 4 had discrepant sodium results.The repeat values were deemed correct.The first patient sample initially resulted in a sodium value of 132 mmol/l and it repeated as 140 mmol/l.The second patient sample initially resulted in a sodium value of 130 mmol/l and it repeated as 136 mmol/l.The third patient sample initially resulted in a sodium value of 134 mmol/l and it repeated as 140 mmol/l.The fourth patient sample initially resulted in a sodium value of 134 mmol/l and it repeated as 140 mmol/l.
Additional Manufacturer Narrative
The serial number of the c501 analyzer is (b)(6).The field service engineer checked the analyzer.The sipper syringe seal was found to be worn.The ise sipper syringe seals were replaced.The ise waste port was cleaned.The fluidics and reaction cell rinse mechanism vacuum lines were decontaminated.The rinse mechanism water rinse volume was low, so it was adjusted.Probe washing was checked.The gear pump pressure was acceptable.The sample syringe plunger set screw was checked.The vacuum pump diaphragms were worn, so the vacuum head valves and diaphragms were replaced.The vacuum elbows were cleaned.Ise checks were acceptable.Calibration passed.The sample probe was cleaned and precision studies were performed.All checks passed.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and controls were acceptable prior to the event.Controls for sodium were outside of range after running the affected samples.A review of the alarm trace data showed a sample short alarm.The investigation determined the service actions resolved the issue.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• Brand Name: COBAS 6000 C (501) 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 46250-0457
• MDR Report Key: 22104934
• Report Number: 1823260-2025-01646
• Device Sequence Number: 18177689
• Product Code: JJE
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: 05860636001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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 Age: 24 YR
• Patient Sex: Female