MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	06473245001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they were having rinse unit issues on their cobas 8000 c702 module causing controls to recover outside of range for multiple assays.The issue occurred after maintenance was performed on the rinse mechanism.Two patient samples had discrepant results when tested with ca2 (calcium).The first sample initially resulted in a calcium value of 6.8 mg/dl and it was repeated on a second analyzer, resulting in a value of 9.6 mg/dl.The second sample initially resulted in a calcium value of 5.6 mg/dl and it was repeated on a third analyzer, resulting in a value of 9.5 mg/dl.The repeat values were deemed correct.
Additional Manufacturer Narrative
The calcium reagent lot number and expiration date were requested, but not provided.The field service engineer found leaking rinse tubing.The tubing was replaced.Mechanism checks were performed, the rinse volumes were adjusted, the incubator bath exchange maintenance was performed, and a cell blank was performed.The customer ran calibration and controls.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 8000 C 702 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: 18641880
• Report Number: 1823260-2024-00324
• Device Sequence Number: 17966356
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 02/05/2024

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: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 02/05/2024
• 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