MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 IMMUNOASSAY ANALYZER; IMMUNOCHEMISTRY ANALYZER

Model Number	E411 RACK
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable high total psa elecsys result for one patient from the cobas e 411 rack analyzer.The initial result was 16.58 ng/ml and the repeat result on (b)(6) 2023 after defrosting the sample was 0.531 ng/ml.The questionable result was reported outside of the laboratory and was questioned by the laboratory director, as it did not match the history of the patient.The reagent lot number was 59860000 with an expiration date of 30-jun-2023.
Additional Manufacturer Narrative
The quality control was in range on the date of the event.The field service engineer found the measuring cell was due for replacement.He replaced the measuring cell, adjusted the tip/vessel carrier timing belt, and performed photomultiplier high voltage adjustment.The customer ran qc and performed precision testing that passed.The field service engineer performed a system volume check and blank cell calibration which passed.The customer found the aliquot of the sample material contained a foreign substance.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS E 411 IMMUNOASSAY ANALYZER
• 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: 16254737
• Report Number: 1823260-2023-00264
• Device Sequence Number: 5565973
• Product Code: JJE
• UDI-Device Identifier: 07613336165997
• UDI-Public: 07613336165997
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 04775201973
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/23/2023
• 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