MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT; IMMUNOCHEMISTRY ANALYZER

Catalog Number	08454345001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable cea elecsys e2g result from the cobas e 801 analytical unit.The initial result was 6.74 ng/ml and was reported outside of the laboratory to the patient who complained about the result.On 13-nov-2023, the same sample was repeated and the result was 0.837 ng/ml.
Additional Manufacturer Narrative
The reagent lot number was 725519.The expiration date was requested but was not provided.The calibration and qc data were acceptable.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.The provided data do not indicate a reagent or instrument issue.The event was consistent with a preanalytic handling issue by the customer.

• Brand Name: COBAS E 801 ANALYTICAL UNIT
• Common Device Name: IMMUNOCHEMISTRY 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: 18248190
• Report Number: 1823260-2023-03818
• Device Sequence Number: 6644971
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/16/2024
• 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