MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR; THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM

Catalog Number	08496609190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Hyperthyroidism (4924)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e411 analyzer serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter complained of high results not corresponding to the clinical picture for multiple patient samples tested for elecsys anti-tshr (anti-tshr) on a cobas e 411 analyzer (rack system) since (b)(6) 2025.The following examples for 2 patient samples tested on (b)(6) 2025 were provided.Patient 1 result from the e411 analyzer was 1.75 u/l.The result at another laboratory using an unspecified cobas 8000 system was 0.88 u/l.Patient 2 result from the e411 analyzer was 2.75 u/l.The result at another laboratory using an unspecified cobas 8000 system was < 0.8 u/l.The field application specialist (fas) found that qc was initially acceptable but shifted after replacing the reagent and performing calibration.Liquid flow cleaning (lfc) and measuring cell preparation were performed.Calibration and qc were completed, and patient samples were run.The issue was not resolved.Qc was within range but was trending high.Patient results were also high.The field service engineer (fse) found that qc for some tests was outside of the acceptable range.The measuring cell was replaced.A cell blank and calibrations were completed.After the measuring cell was replaced, the customer complained of another questionable result.On (b)(6) 2025 patient 3 result from the e411 analyzer was 2.37 u/l.The result using an unspecified elecsys reagent at another laboratory was 0.90 u/l.The lower results were believed to be correct.
Additional Manufacturer Narrative
Issues have been identified with the elecsys anti-tshr assay, particularly around the 1.75 iu/l medical decision point.Roche diagnostics has issued an urgent medical device correction for this issue, entitled "elecsys® anti-tshr assay ¿ deviations on cobas® e 411, 402, and 801 analyzers." this correction has been reported to fda.Roche diagnostics investigated and confirmed the customers' allegations.The root cause for the variations in the elecsys anti-tshr assay was an insufficiency of the assay's routine production process.For the platform-to-platform deviation (cobas e 411 vs.Cobas e 402/e 801), differences arose due to an insufficient alignment concept between the platforms.These variations were further influenced by updates to the routine production process for this assay.For the lot-to-lot deviation on e 411, measures taken to enhance robustness led to additional shifts.Customers were advised to immediately discontinue using and discard the affected lot numbers: 840183 and 874011 on the cobas e402/e801 analyzer 840177 on the cobas e411 analyzer customers were advised to switch to the new unaffected lot numbers: 908953 on the cobas e402/e801 analyzer 906872 on the cobas e411 analyzer the cobas e601 and e602 modules are not affected and can be used with all currently available lots and with the upcoming lots without restrictions.

• Brand Name: ELECSYS ANTI-TSHR
• Common Device Name: THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23349700
• Report Number: 1823260-2025-04275
• Device Sequence Number: 20822564
• Product Code: JZO
• UDI-Device Identifier: 07613336160305
• UDI-Public: 07613336160305
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K193313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 08496609190
• Device Lot Number: 84017701
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/11/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 98103
• Patient Sequence Number: 1
• Patient Sex: Unknown