MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number	07026935190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii, elecsys anti-tpo, and elecsys anti-tg on a cobas e 801 analytical unit and a cobas e 411 analyzer.This medwatch will apply to the anti-tpo 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 anti-tg assay.The sample resulted in the following values when tested on the e 801 analyzer: ft3 = 28.4 pmol/l.Anti-tpo = > 600 iu/ml.Anti-tg = > 4000 iu/ml.The sample resulted in the following values when tested on the e411 analyzer: ft3 = 8.7 pmol/l.Anti-tpo = 230.4 iu/ml.Anti-tg = 200.1 iu/ml.
Additional Manufacturer Narrative
The serial number of the e801 analyzer is 42k5-10.The serial number of the e411 analyzer was requested, but not provided.The patient's sample was provided for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Investigations performed with the patient's sample determined that it contains an interfering factor against the streptavidin component of the ft3, anti-tpo, and anti-tg assays.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.".

• Brand Name: ELECSYS ANTI-TPO
• Common Device Name: SYSTEM, TEST, THYROID AUTOANTIBODY
• 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: 22816189
• Report Number: 1823260-2025-02512
• Device Sequence Number: 18318776
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051890
• 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): 09/25/2025

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: 09/30/2025
• Device Catalogue Number: 07026935190
• Device Lot Number: 84682901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/25/2025
• 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 Age: 35 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Race: Asian