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

Catalog Number	08496609190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Hyperthyroidism (4924)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-tshr results for multiple patient samples on a cobas e411 module.The customer provided an example of discrepant results for 15 patient samples tested.The customer alleged an increased number of conspicuously borderline positive patients, and that the results did not match the medical doctor's expectations for the patients' results.For sample 1, the result was 10.56 iu/l.For sample 2, the result was 1.95 iu/l.For sample 3, the result was 1.96 iu/l.For sample 4, the result was 1.88 iu/l.For sample 5, the result was 2.27 iu/l.For sample 6, the result was 1.70 iu/l.For sample 7, the result was 2.13 iu/l.For sample 8, the result was 2.08 iu/l.For sample 9, the result was 2.16 iu/l.For sample 10, the result was 1.71 iu/l.For sample 11, the result was 1.93 iu/l.For sample 12, the result was 2.22 iu/l.For sample 13, the result was 1.89 iu/l.For sample 14, the result was 1.65 iu/l.For sample 15, the result was 1.42 iu/l.
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: 23512419
• Report Number: 1823260-2025-04573
• Device Sequence Number: 21238079
• Product Code: JZO
• UDI-Device Identifier: 07613336160305
• UDI-Public: 07613336160305
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 08496609190
• Device Lot Number: 840177
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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