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	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of a falsely-depressed atellica im thyroid stimulating hormone 3-ultra (tsh3-ul) result which was discordant relative to alternate-method testing.The customer has observed a case where the atellica im tsh3-ul result is below the assay's measuring interval (<0.008 miu/l), but testing using an alternate method produced a higher result.The alternate-method result was considered consistent with the patient's clinical presentation, and was accepted as correct.There are no allegations of patient harm, and no reports of modification of treatment in association with the observed result discordance.
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 healthcare diagnostics is investigating.
Additional Manufacturer Narrative
Mdr 1219913-2022-00264 was initially filed on 2022-09-12.Additional information, 2022-10-13: siemens has concluded the investigation.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.Siemens reviewed the available information, and concluded that an extremely rare genetic variant is the most likely cause of the undetectable tsh3-ul result.The instructions for use (ifu) for atellica im thyroid stimulating hormone 3-ultra (tsh3-ul) states the following, under limitations: "as with any immuno-recognition measurement of a peptide, extremely rare genetic variants may exhibit varying degrees of detection." a product performance issue has not been identified.The customer is operational; no further investigation is required.Note: in section h6, the codes for investigation findings and investigation conclusion have been 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: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 15406076
• Report Number: 1219913-2022-00264
• Device Sequence Number: 6839977
• 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): 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): 11/03/2022

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: 04/26/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995703
• Device Lot Number: 396
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown