MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR ANTI-TG (ATG); SYSTEM, TEST, THYROID AUTOANTIBODY

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	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Discordant, low advia centaur xp anti-thyroglobulin (atg) assay results were observed for two patient samples in a method comparison.The initial results from the advia centaur xp analyzer were reported to the physician, and were not questioned.However, repeat testing of the samples by alternate methods produced clinically contradictory results; the repeat results were observed in the context of method-comparison testing, and were not reported.There are no known reports of patient intervention or adverse health consequences due to the discordant atg results.
Additional Manufacturer Narrative
A customer from outside the united states observed advia centaur xp anti-thyroglobulin (atg) patient results which were discordant relative to results obtained using alternate methods.Siemens is investigating.The product's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." mdr 1219913-2022-00001 was submitted for the same event.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2022-00002 on 2022-01-05.Additional information, 2022-02-10: siemens has concluded the investigation.A customer from outside the united states observed advia centaur xp anti-thyroglobulin (atg) patient results which were discordant relative to results obtained using alternate methods.Discordance was identified when comparing results among three assays: advia centaur atg, advia centaur atgii, and immulite 2000 atg.Siemens notes that patient results may vary among these assays for a number of reasons, including differences in assay architecture, standardization, and diagnostic cutoff, as well as the variability in the effect of anti-tg antibodies.[antibodies to thyroglobulin are frequently present in thyroid cancer patients, and can interfere with measurements to differing extents.].No product problem was identified.The customer is operational, and no further investigation is required.Notes: in section h6, the codes for type of investigation, investigation findings and investigation conclusion have been updated on the basis of the investigation results.Mdr 1219913-2022-00001 was submitted for the same event.

• Brand Name: ADVIA CENTAUR ANTI-TG (ATG)
• Common Device Name: SYSTEM, TEST, THYROID AUTOANTIBODY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13167803
• Report Number: 1219913-2022-00002
• Device Sequence Number: 4146579
• Product Code: JZO
• UDI-Device Identifier: 00630414579214
• UDI-Public: 00630414579214
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K012777
• 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): 02/25/2022

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: 04/25/2022
• Device Model Number: N/A
• Device Catalogue Number: 10492398
• Device Lot Number: 353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• 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