MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM ANTI-THYROGLOBULIN II (ATGII)

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported the observation of discordant anti-thyroglobulin ii (atgii) patient result when compared to historical results obtained for the patient with the alternate atg method.Method comparison study between the alternate atg method and atellica im atgii assay was performed.As stated in the limitations section of the atellica im anti-thyroglobulin ii (atgii) instructions for use (ifu), ¿anti-thyroglobulin values obtained from different test methods will vary and cannot be used interchangeably.¿ there is no expectation that atellica im atgii and alternate test methods will produce similar results.The customer does not have patient sample available for siemens investigation purposes.
Event or Problem Description
The customer reported the observation of discordant anti-thyroglobulin ii (atgii) patient result with the atellica im lot: 034 when compared to historical results obtained for the patient with the alternate atg method.The customer alleges that this issue was observed upon installation of the assay on (b)(6) 2024.However, the customer has reported this observation of discordance to siemens retrospectively.The customer contacted siemens on 07-nov-2024 and provided representative patient data documented in section b6.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2024-00482 was initially filed on 28-nov-2024.Additional information (02-dec-2024): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states reported observation of discordant anti-thyroglobulin ii (atgii) patients results with the atellica im lot when compared to historical results obtained for the patients with the alternate atg method.Siemens evaluated customer data and shared a customer bulletin entitled "introducing the new atellica im anti-thyroglobulin ii (atgii) assay (ous)" that shows the performance of the atellica im atgii assay vs.Other atg commercial assays.The data showed that there was no 100% clinical concordance between atgii and alternate atg method.Based on the available information, the measured concentration of atg in each specimen can vary between assays due to differences in assay design and methodology.There is no expectation that the atellica im atgii assay and alternate test methods will produce similar results.A specific cause for the discordant results was unable to be determined.A product problem was not identified.The customer is operational, and no further actions are required.Note: in section h6, codes for investigation findings and investigation conclusions were updated.

• Brand Name: ATELLICA IM ANTI-THYROGLOBULIN II (ATGII)
• Common Device Name: ATELLICA IM ANTI-THYROGLOBULIN II (ATGII)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20804539
• Report Number: 1219913-2024-00482
• Device Sequence Number: 18593536
• Product Code: JZO
• UDI-Device Identifier: 00630414245324
• UDI-Public: (01)00630414245324(10)59388034(17)260209
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT (OUS)
• 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): 12/10/2024

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: 02/09/2026
• Device Model Number: N/A
• Device Catalogue Number: 11201761
• Device Lot Number: 59388034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown