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	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration and controls were acceptable.A general reagent issue can be excluded.Camera images from previously measured samples showed an abnormality in one of the sample tubes which appeared to be part of a cap.This may have hindered probe positioning.The investigation determined the issue is consistent with insufficient pre-analytic sample handling.
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with elecsys anti-tpo on a cobas e 801 module.No questionable results were reported outside of the laboratory.A tube of the first sample initially resulted in anti-tpo values of 37 iu/ml and 9.43 iu/ml.The parent tube of the sample was then repeated, resulting in a value of 9.05 iu/ml.A tube of the second sample initially resulted in an anti-tpo value of 36 iu/ml.The sample was then repeated, resulting in a value of 12.4 iu/ml.A tube of the third sample initially resulted in an anti-tpo value of 36.4 iu/ml.The sample was then repeated, resulting in a value of 12.7 iu/ml.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer was requested, but not provided.The field service engineer cleaned the instrument on 09-feb-2025.The investigation is ongoing.

• 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: 21651820
• Report Number: 1823260-2025-00792
• Device Sequence Number: 9276519
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/30/2025

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: 07026935190
• Device Lot Number: 781973
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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