MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL); THYROID STIMULATING HORMONE IMMUNOASSAY

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	05/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant, depressed thyroid stimulating hormone 3-ultra (tsh3-ul) result was obtained on a patient sample on an atellica im 1600 analyzer compared to results from two alternate methods.The discordant result was not reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed tsh3-ul patient result.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a falsely-depressed atellica im thyroid stimulating hormone 3-ultra (tsh3-ul) result which was discordant relative to alternate-method testing.The instructions for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthineers is investigating.
Additional Manufacturer Narrative
The initial mdr 1219913-2022-00280 was filed on september 9, 2022.A customer from outside of the united states reported a discordant depressed thyroid stimulating hormone 3-ultra (tsh3-ul) result was obtained on a patient sample on an atellica im 1600 analyzer compared to results from two alternate methods.Additional information - september 22, 2022.The sample cannot be sent to siemens for testing.Additional information - september 28, 2022.After reviewing the currently available information, the most likely cause of the undetectable tsh3-ul results is an extremely rare genetic variant.The limitations section of the instructions for use states: "as with any immuno-recognition measurement of a peptide, extremely rare genetic variants may exhibit varying degrees of detection.12".Siemens is continuing to investigate.
Additional Manufacturer Narrative
The initial mdr 1219913-2022-00280 was filed on september 9, 2022 and mdr supplemental 1 was filed on october 10, 2022.A customer from outside of the united states reported a discordant depressed thyroid stimulating hormone 3-ultra (tsh3-ul) result was obtained on a patient sample on an atellica im 1600 analyzer compared to results from two alternate methods.Additional information - october 12, 2022.After reviewing the available information, the most likely cause of the undetectable tsh3-ul results is an extremely rare genetic variant.The limitations section of the instructions for use states: "as with any immuno-recognition measurement of a peptide, extremely rare genetic variants may exhibit varying degrees of detection.12".A product problem was not identified.The customer requires no further support.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL)
• Common Device Name: THYROID STIMULATING HORMONE IMMUNOASSAY
• 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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 15393440
• Report Number: 1219913-2022-00280
• Device Sequence Number: 5007190
• Product Code: JLW
• UDI-Device Identifier: 00630414600178
• UDI-Public: 00630414600178
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K150403
• 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,Followup
• Report Date (Section B): 10/31/2022

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 Model Number: N/A
• Device Catalogue Number: 10995704
• Device Lot Number: 392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 10/12/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/10/2022; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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