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

Catalog Number	06368590190
Medical Device Problem Codes	No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e411 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned dilution results for 1 patient sample tested for elecsys anti-tpo (anti-tpo) on a cobas e 411 analyzer (rack system).The initial result was > 600 iu/ml.The sample was repeated with dilution and the result was 74.70 iu/ml (calculated result 448.2 iu/ml).On (b)(6)2025 the sample was run with no dilution and the result was > 600 iu/ml.The sample was repeated with dilution twice with results of 69.99 iu/ml (calculated result 419.94 iu/ml) and 89 iu/ml (calculated result 445 iu/ml).The customer questioned why the diluted results were lower than the undiluted results of > 600 iu/ml.On (b)(6)2025 the customer repeated the sample using a new diluent and the result with an x5 dilution was 101.2 iu/ml (calculated result 506 iu/ml).On (b)(6)2025 the customer performed additional dilutions with the following results: 1:2 dilution was 314.3 iu/ml (calculated result 628.6 iu/ml).1:8 dilution was 114.0 iu/ml (calculated result 912.4 iu/ml).1:20 dilution was 33.33 iu/ml (calculated result 666.6 iu/ml).No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The results provided relate to the non-linear dilution behavior of anti-tpo.Product labeling states: "samples with anti-tpo concentrations above the measuring range can be diluted manually with diluent universal.The recommended dilution is 1:5.The concentration of the diluted sample must be > 200 iu/ml.After dilution, multiply the result by the dilution factor.Please note: the autoantibodies are heterogeneous and this gives rise to non-linear dilution phenomena for individual samples." 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: 21412043
• Report Number: 1823260-2025-00481
• Device Sequence Number: 9518645
• Product Code: JZO
• UDI-Device Identifier: 04015630929702
• UDI-Public: 04015630929702
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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): 04/03/2025

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: 06368590190
• Device Lot Number: 827061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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