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

Catalog Number	05641489001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with gluc3 (glucose) on a cobas 8000 c 701 module.No questionable results were reported outside of the laboratory.The sample initially resulted in a glucose value of 520 mg/dl and it repeated as 81 mg/dl.The repeat value was deemed correct.
Additional Manufacturer Narrative
The glucose reagent lot number and expiration date were requested, but not provided.The field service engineer found a hole in the rinse mechanism tubing.The tubing was replaced.The customer performed controls successfully.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 8000 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
• MDR Report Key: 18440492
• Report Number: 1823260-2024-00021
• Device Sequence Number: 17882339
• Product Code: JJE
• UDI-Device Identifier: 04015630928255
• UDI-Public: 04015630928255
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• 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): 01/03/2024

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: 05641489001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/03/2024
• 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: 64 YR
• Patient Sex: Male