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

Catalog Number	04775201973
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas e411 rack cu is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys troponin t g5 stat result from a patient sample tested on the cobas e411 rack cu.The initial result was reported to the provider.The discrepant results were noted when the reporter was performing a reagent lot-to-lot comparison test.The initial result was 93 ng/l.The first repeat result was 7 ng/l.The second repeat result was 7 ng/l.The third repeat result was 7 ng/l.The repeat result was deemed correct.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) updated.The investigation reviewed the last calibration performed on 21-apr-2024 and the calibration signals were within range.There was no influence of calibration on the issue.The investigation reviewed the qc and the results were within range.The investigation reviewed the alarm trace and no issues were noted on the date of event.The field service engineer (fse) indicated that the customer suspected a possible clot in the patient sample.A general reagent problem was not present because the qc before the event was within range.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 19183523
• Report Number: 1823260-2024-01282
• Device Sequence Number: 7118982
• Product Code: JJE
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 06/28/2024
• 2 Devices were Involved in the Event: 1 2

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: 04775201973
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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 Age: 52 YR
• Patient Sex: Male