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

Model Number	E411 RACK
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and qc data were acceptable.Therefore general reagent issues were excluded.Liquid level detection alarms on the day the events indicate possible improper sample pre-analytics.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
There was an allegation of questionable results from the cobas e411 rack analyzer.Patient 1 initial total psa elecsys result was 0.02 ng/ml and was reported outside of the laboratory.The treating physician questioned the result as it did not match the patient's clinical history.On (b)(6) 2022, the repeat result was 1.29 ng/ml.On (b)(6) 2022, patient 2 initial insulin elecsys result was 0.04 uu/ml and was not reported outside of the laboratory.The repeat result was 27 uu/ml.The total psa reagent lot number was 648973 with an expiration date of 31-jan-2024.The insulin reagent lot number was 586607 with an expiration date of 31-mar-2023.

• 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: 16016109
• Report Number: 1823260-2022-04108
• Device Sequence Number: 20517892
• Product Code: JJE
• UDI-Device Identifier: 04015630913060
• UDI-Public: 04015630913060
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K961481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2022

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: 11/30/2022
• Initial Report FDA Received Date: 12/20/2022
• 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: Male