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	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas pro sb is (b)(6) the investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys anti-tpo results from one patient sample tested on the cobas pro sb.On (b)(6) 2025: the initial result from the analyzer was 16.40 u/ml.The patient's primary care physician disputed the initial result.On (b)(6) 2025: the first repeat result from the analyzer was 17.80 u/ml.The second repeat result from another laboratory that uses a beckman analyzer was 132.1 ku/l.
Additional Manufacturer Narrative
On (b)(6) 2025, new elecsys anti-tpo results of the patient sample were reported: the repeat result at 1:2 was <9.00 u/ml.The repeat result at 1:5 was <9.00 u/ml.The repeat result at 1:10 was <9.00 u/ml.Based on the dilution results, the investigation excluded the presence of an interferent in the patient sample.The calibration and qc results are acceptable.Product labeling states "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21547035
• Report Number: 1823260-2025-00661
• Device Sequence Number: 7018338
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/19/2025

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: 06/30/2025
• Device Catalogue Number: 07026935190
• Device Lot Number: 83705601
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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