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

Catalog Number	08496609190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hypothyroidism (4860)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).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 the 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.
Event or Problem Description
There was an allegation of questionable elecsys anti-tshr assay results for an unknown number of patient samples tested on a cobas e 411 analyzer (rack system) compared to a different method.It was reported that samples were initially positive, and when repeated using a different method at another laboratory and the results were negative.The following example results were provided for a patient sample: on (b)(6) 2025: 1.90 iu/l (accompanied by a data flag), (b)(6) 2025: chemiluminescent microparticle immunoassay (cmia): 1.56 ui/l (negative), (b)(6) 2025: 2.33 iu/l (accompanied by a data flag).
Additional Manufacturer Narrative
Medwatch field h9 was updated.

• 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: 23717413
• Report Number: 1823260-2025-04947
• Device Sequence Number: 12973129
• 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): 12/12/2025

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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/12/2025
• 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 Age: 69 YR
• Patient Sex: Female