MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS C 701 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05168589190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The creatinine reagent lot number was 84777601.The expiration date was not provided.The field service engineer found the reagent probe outside rinse level was too low.He adjusted the rinse levels for all reagent probes, adjusted the gear pump, and replaced sample probe a.He ran precision testing and qc which was acceptable.The analyzer alarm trace contained abnormal aspiration (sample probe), abnormal aspiration (sample probe b), sample clot detection, and sample foam detection alarms.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable creatinine plus ver.2 results from the cobas 8000 cobas c 701 module.The initial result was 1.31 mg/dl.The repeat result from another c701 analyzer was 0.82 mg/dl.The repeat result was believed to be correct.

• Brand Name: COBAS 8000 COBAS C 701 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: 21652720
• Report Number: 1823260-2025-00803
• Device Sequence Number: 13080526
• Product Code: JJE
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K024098
• 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): 03/20/2025

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: 05168589190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/20/2025
• 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: 83 YR
• Patient Sex: Male