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

Model Number	E411 RACK
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys anti-tpo assay on a cobas e 411 analyzer (rack system).The sample initially resulted in a value of 600 iu/ml.The sample was repeated two times, resulting in values of 9.3 iu/ml and 10.7 iu/ml.The questionable result was reported outside of the laboratory.The result of 9.3 iu/ml was deemed correct.The anti-tpo reagent lot number was 62835101 with an expiration date of 30-apr-2022.
Additional Manufacturer Narrative
The customer was recommended to centrifuge frozen samples after they are thawed and prior to their testing.The field service engineer replaced the pinch valve tubing and syringe seals.Instrument performance testing passed successfully.The investigation is ongoing.
Additional Manufacturer Narrative
The last calibration performed on 11-oct-2022 was normal with no alarms.Quality control data was not provided.Upon review of the alarm trace, no relevant alarms were observed.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: 15731252
• Report Number: 1823260-2022-03485
• Device Sequence Number: 2996278
• Product Code: JJE
• UDI-Device Identifier: 04015630929702
• UDI-Public: 04015630929702
• 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): 12/01/2022

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: 10/11/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/01/2022
• 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: Unknown