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	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sections d1, d2a, d2b, d4, g1, and g4 were updated.The sample was a plasma sample.The calibration was last performed on (b)(6) 2024 and it was acceptable.The field service engineer found an issue with the rinse tubing.He replaced the rinse mechanism tubing, the check valve, and the vacuum vessel and adjusted the rinse levels.Precision studies were performed and they were within specifications.The service actions (replacing the rinse mechanism tubing, the check valve, and the vacuum vessel and adjusting the rinse levels) resolved the issue.No further issues were reported afterward.
Event or Problem Description
We received an allegation of questionable ise results for 1 patient sample tested on a cobas 6000 c501 analyzer.Results for the sodium (na) test were affected.Initial result: 150 mmol/l.The customer questioned the initial result as it did not match the patient's previous results and repeated the sample.Repeat result: 143 mmol/l.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The na electrode expiration date was not provided.The c501 analyzer serial number was (b)(6).Qc was acceptable.The investigation is ongoing.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 19741354
• Report Number: 1823260-2024-02026
• Device Sequence Number: 17057325
• Product Code: JJE
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 07/25/2024
• 2 Devices were Involved in the Event: 1 2

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: R9841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 92 KG