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	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of falsely-depressed atellica im thyroid stimulating hormone 3-ultra (tsh3-ul) results which were discordant relative to repeat testing.On (b)(6) 2022, the customer noted control chart results beyond expected range (negative bias to results) and repeated tsh3-ul testing from this period.Samples from two patients produced repeat results which were higher than the initial results.The higher results were reported 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 falsely-depressed atellica im thyroid stimulating hormone 3-ultra (tsh3-ul) results which were discordant relative to repeat 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 1219913-2022-00252 was initially filed on 2022-08-19.Additional information, 2022-11-21: siemens has concluded the investigation.A customer from outside the united states reported observation of falsely-depressed atellica im thyroid stimulating hormone 3-ultra (tsh3-ul) results which were discordant relative to repeat testing.The customer osberved below-range quality control results and discordant , depressed patient results when using four particular tsh3-ul reagent packs; other reagent packs from the same kit lot did not demonstrate any issues.Siemens tested a reagent pack returned from the customer, and reproduced the customer's observation of depressed results.Testing of a reagent pack from the same lot, but from internal siemens supply, produced results within expected ranges.Investigation showed that the middle well fitc reagent in the customer-returned reagent pack was responsible for the depressed assay results.This reagent is light-sensitive and exposure to light will cause degradation which results in depression of results.Note: the assay's instructions for use (ifu) advises the following, under storage and stability: "protect the product from heat and light sources." additionally, product labeling contains symbology indicating the same.Siemens has concluded that light exposure is the most likely cause of the observed result depression for the four indicated reagent packs.No product performance issue has been identified.The customer is operational and no additional investigation is required.

• 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: 15258554
• Report Number: 1219913-2022-00252
• Device Sequence Number: 6614092
• Product Code: JLW
• UDI-Device Identifier: 00630414600178
• UDI-Public: 00630414600178
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 12/05/2022

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: 12/16/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995704
• Device Lot Number: 390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 12/05/2022
• 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