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	11/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration was last performed on (b)(6) 2024 and it was acceptable.The customer mentioned that they were having qc issues.The field service engineer determined that the issue was due to a defective lot of internal standard reagent (component failure).The customer resolved the issue by loading a new lot of internal standard reagent on both systems.They then performed calibrations and qc with successful results.The customer verified that the system was performing within specifications by testing patients' samples between two different systems and all results matched.No further issues were reported after the service visit.
Event or Problem Description
We received an allegation of questionable ise results for 60 patients' samples tested on a cobas 6000 c501 (ul) v module.Results for the sodium (na) test were affected.Discrepant results for 2 patients' samples were provided.Sample 1 (patient 1): initial result: 131 mmol/l.Repeat result: 137 mmol/l.Sample 2 (patient 2): initial result: 131 mmol/l.Repeat result: 139 mmol/l.Qc issues and ongoing low na values prompted the repeat of the samples on (b)(6) 2024.The repeat results were deemed to be correct.Out of the 60 patients' results, reportedly, an amended report with 46 correct results was issued.

• 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
• MDR Report Key: 20906394
• Report Number: 1823260-2024-03623
• Device Sequence Number: 13033418
• Product Code: JJE
• UDI-Device Identifier: 04015630946402
• UDI-Public: 04015630946402
• 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
• Report Date (Section B): 12/11/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/11/2024
• 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 Sex: Unknown