MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (RACK SYSTEM); IMMUNOCHEMISTRY ANALYZER

Model Number	E411 RACK
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for an unspecified number of patient samples tested with multiple assays on the cobas e 411 analyzer (rack system).The customer provided examples of discrepant results for one patient sample tested with the elecsys ft4 iv assay and a second patient sample tested with the elecsys probnp ii immunoassay.No questionable results were reported outside of the laboratory.No units of measure were provided.The first patient sample initially resulted in a ft4 value of 3 and it repeated as 12.The second patient sample initially resulted in a probnp value of < 10 and it repeated as 200.The ft4 reagent lot number was 586657 and the probnp reagent lot number was 650156.The reagent expiration dates were requested, but not provided.
Additional Manufacturer Narrative
Medwatch field e1.Phone number was provided as (b)(6).H3: na.
Additional Manufacturer Narrative
The customer stated that the controls were ok.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS E 411 ANALYZER (RACK SYSTEM)
• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16862488
• Report Number: 1823260-2023-01497
• Device Sequence Number: 6100077
• Product Code: JJE
• UDI-Device Identifier: 07613336191538
• UDI-Public: 07613336191538
• Combination Product (Y/N): N
• Initial Reporter Country: GP
• PMA/510(K) Number: K961481
• 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): 05/24/2023

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 Model Number: E411 RACK
• Device Catalogue Number: 04775201001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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