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

Catalog Number	06368590190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e411 first analyzer was not provided.The serial number of the second e411 analyzer 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 three cobas pure e 402 analytical units and two cobas e411 analyzers.This medwatch is for the cobas e 411 analyzer elecsys anti-tpo reagent.Please refer to the medwatch with a1.Patient identifier (b)(6) for the cobas pure e 402 analytical unit elecsys anti-tpo reagent.On (b)(6) 2024: the initial result from the first e 402 analyzer was 250 iu/ml or 279.0 iu/ml.The first repeat result from the first e 411 analyzer was 40.6 iu/ml or 40 iu/ml.On (b)(6) 2024: the second repeat result from the second e 402 analyzer was 227 iu/ml.The third repeat result from the third e 402 analyzer was 256 iu/ml.The fourth repeat result from the second e 411 analyzer was 48.86 with a data flag.The initial result was not reported outside the laboratory as it did not fit the clinical picture (the patient had previous normal results).The reporter was unsure which result was deemed correct.
Additional Manufacturer Narrative
The patient sample was not available for investigation.The calibration and qc data results were within the specified ranges.The alarm trace did not indicate any issues.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 21148862
• Report Number: 1823260-2025-00125
• Device Sequence Number: 18425544
• Product Code: JZO
• UDI-Device Identifier: 04015630929702
• UDI-Public: 04015630929702
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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): 04/29/2025

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: 12/23/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 04/29/2025
• 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: 21 YR
• Patient Sex: Male