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

Catalog Number	05860636001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).The qc recovery was acceptable.The field service engineer (fse) found that the slider on the ise sample mechanism was worn, and the rinse tubing had a pinhole.He replaced the slider and the rinse tubing.He also confirmed the rinse levels and mechanical adjustments for the ise sample mechanism and verified air purges.He performed primes, mechanical checks, qc, and precision studies, and they were within specifications.The investigation is ongoing.
Event or Problem Description
We received an allegation of a questionable sodium electrode result for 1 patient sample tested on a cobas 6000 c 501 (ul) v module.Initial result: 175 mmol/l.The initial result did not match the patient's history, prompting the repeat of the sample on a different analyzer.Repeat result: 130 mmol/l.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
Sections d1, d2a, d2b, d4, and g1 were updated.The calibration was last performed on 08-aug-2025, and it was acceptable.The alarm trace showed multiple abnormal probe sucking alarms on the date of the event, near the time the sample was processed.This is an indication of possible poor sample quality.The service actions performed by the engineer resolved the issue.No further issues were reported after the service visit.

• 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: 22990781
• Report Number: 1823260-2025-02773
• Device Sequence Number: 18344600
• Product Code: JJE
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/24/2025

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: BHW84
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 09/24/2025
• 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