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

Model Number	TSH
Medical Device Problem Codes	Low Test Results (2458); Low Readings (2460); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For one event: 1.Summary of investigation results: the investigation is ongoing.2.Summary of follow-up/corrective actions taken: the investigation is ongoing.3.Device returned to manufacturer? no.4.Device labeled "for single use?" no.5.Device reprocessed and reused? no.
Event or Problem Description
1.Describe the event: the initial reporter complained of a discrepant result for 1 patient tested for elecsys tsh v2 on a cobas e 411 analyzer (disk system).2.Patient age range: asku.3.Patient weight range: asku.4.Patient sex breakdown: asku.5.Patient race breakdown: asku.6.Patient ethnicity breakdown: asku.
Additional Manufacturer Narrative
For the one (1) event summarized: 1.Summary of investigation results: the customer did not report any other issues after the service.The investigation determined that the service actions resolved the issue.The investigation did not identify a product problem.2.Summary of follow-up/corrective actions taken: the investigation included a review of the customer's calibration and qc data; the results were within the specified ranges.The field service engineer inspected the analyzer and determined that fluctuating humidity levels in the laboratory had caused the event.He verified the analyzer's performance with successful mechanism checks.Medwatch fields d.Device identification, g1 contact office - manufacturing site, and g4 pma / 510k (premarket numbers) were updated.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 22587232
• Report Number: 1823260-2025-02264
• Device Sequence Number: 9282903
• Product Code: JJE
• UDI-Device Identifier: 07613336157626
• UDI-Public: 07613336157626
• Combination Product (Y/N): N
• PMA/510(K) Number: K961481
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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?: No
• Device Model Number: TSH
• Device Catalogue Number: 04775279973
• Device Lot Number: 838250
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown