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	06/20/2022
Type of Reportable Event	Malfunction
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.
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 the result from an alternate method.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
Siemens filed the initial mdr 1219913-2022-00298 on (b)(6) 2022.Additional information: sep 20, 2022.Patient sample in question is not sent to siemens for internal testing.Customer confirmed that the sample type is serum.Section d8: was this device serviced by a third party? updated to no.Additional information: oct 12, 2022.An outside the united states customer observed a discordant low result of <0.008 uiu/ml on the atellica im thyroid stimulating hormone 3-ultra (tsh3-ul) assay on one patient sample with reagent lot 394.The tsh3-ul result for the patient was normal on an alternate method.Most likely the cause of the undetectable tsh3-ul result is from an extreme rare genetic variant.Under the limitations section of the ifu for tsh3-ul, it states the following: "as with any immuno-recognition measure of a peptide, extreme rare genetic variants may exhibit varying degrees of detection." no product problem is observed.The customer is operational.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: 15410946
• Report Number: 1219913-2022-00298
• Device Sequence Number: 5894540
• Product Code: JLW
• UDI-Device Identifier: 00630414600161
• UDI-Public: 00630414600161
• 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): N
• 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): 11/09/2022

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: 02/21/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995703
• Device Lot Number: 394
• 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: 09/20/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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