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

Catalog Number	08496633190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-tshr results from the cobas e 801 analytical unit.Sample 1 (b)(6) 2024) initial result was 40 iu/l with a data flag.The automatic repeat result was 39.8 iu/l.The sample was tested in another lab, and the result was 108 iu/l.Sample 2 (b)(6) 2015) initial result was 40 iu/l with a data flag.The result with a 1:5 manual dilution was 199.5 iu/l.The result with a 1:10 dilution was 312 iu/l.This result was reported outside of the laboratory.Sample 3 (b)(6) 2025) initial result was 40 iu/l with a data flag.The result with a 1:3 manual dilution was 120 iu/l.The result with a 1:5 dilution was 133 iu/l.This result was reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation did not find a specific product issue.The anti-tshr assay is specifically designed to detect auto-antibodies against the tsh receptor.Per product labeling for the assay: the autoantibodies are heterogeneous and this gives rise to non-linear dilution phenomena for certain individual samples.

• Brand Name: ELECSYS ANTI-TSHR
• Common Device Name: THYROID AUTOANTIBODY TEST
• 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: 23365547
• Report Number: 1823260-2025-04301
• Device Sequence Number: 9931426
• Product Code: JZO
• UDI-Device Identifier: 07613336160329
• UDI-Public: 07613336160329
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 08496633190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/21/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown