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

Catalog Number	07026935190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).Sample material from the patient was requested for further investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-tpo results for multiple samples from one patient while using the cobas e 801 analytical unit.The customer suspected interference by biotin taken by the patient.On (b)(6) 2026, sample 1 result was 18.1 u/l.This was the beginning of biotin supplementation by the patient.On (b)(6) 2026, sample 2 result was 87.4 iu/ml.The repeat result was 77.7 iu/ml.Biotin supplementation by the patient was stopped.On (b)(6) 2026, the result using a vidas analyzer was <0.8 iu/ml.On 26-jan-2026, sample 3 result was 14.1 iu/ml.On 26-jan-2026, the result using a vidas analyzer was <0.8 iu/ml.
Additional Manufacturer Narrative
Three samples from the patient were submitted for investigation.For the sample from 21-jan-2026: the testing found that the high concentration of biotin caused the falsely high result generated with elecsys anti-tpo by exceeding the stated threshold for biotin of 10 ng/ml.For the other two samples: the difference in the numeric results between elecsys and vidas devices were due to methodological differences.The clinical interpretation for both results was negative, as the results were below the cut-off.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.There was no product problem found.

• 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: 24320699
• Report Number: 1823260-2026-00495
• Device Sequence Number: 9966439
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 04/08/2026

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: 06/30/2026
• Device Catalogue Number: 07026935190
• Device Lot Number: 91264201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTORIS; BIOTINOZIN (10 MG BIOTIN + 25 MG ZINC); DIURED; EVENING PRIMROSE OIL; FUROSEMIDUM; KALIPOZ; VALZEC; VITAMIN A + E
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White