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

Catalog Number	08496633190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medwatch field e1.Facility name - (b)(6).The patient's sample was provided for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii, elecsys ft4 iv, and elecsys anti-tshr on a cobas e 801 analytical unit.The sample results measured on the e 801 analyzer did not compare to results measured using the abbott methods.This medwatch will apply to the anti-tshr assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft4 assay.The results measured on the e 801 analyzer are as follows: ft3 = 12.2 pmol/l (reference range = 3.1 - 6.8 pmol/l),, ft4 = 59.9 pmol/l (reference range = 12 - 22 pmol/l), anti-tshr tested on (b)(6) 2025 = 14.00 iu/l (positive).The results measured using the abbott method are as follows: ft3 = 4.08 pmol/l (reference range = 3.45 - 5.5 pmol/l), ft4 = 14.08 pmol/l (reference range = 11.0 - 17.7 pmol/l), anti-tshr tested on (b)(6) 2025 = <0.7 iu/l (negative).
Additional Manufacturer Narrative
Investigations of the patient sample determined it contains an interfering factor against the ruthenium component of the anti-tshr assay.Per product labeling, "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• 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: 22088253
• Report Number: 1823260-2025-01620
• Device Sequence Number: 6907160
• Product Code: JZO
• UDI-Device Identifier: 07613336160329
• UDI-Public: 07613336160329
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/27/2025

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: 10/31/2025
• Device Catalogue Number: 08496633190
• Device Lot Number: 80193802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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