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

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	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a discordant falsely depressed thyroid stimulating hormone 3-ultra (tsh3-ul) result for a patient sample, on atellica im 1600 analyzer.The initial result was not reported to the physician(s).The sample was repeated on an alternate atellica im analyzer, and the result was higher compared to the initial result.The higher result was considered as correct result.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed tsh3-ul result.
Additional Manufacturer Narrative
An outside the united states customer obtained a discordant falsely depressed thyroid stimulating hormone 3-ultra (tsh3-ul) result for a patient sample, on atellica im 1600 analyzer.The initial result was not reported to the physician(s).The sample was repeated on an alternate atellica im analyzer, and the result was higher compared to the initial result.The higher result was considered as correct result.The quality controls (qc) and calibrations were valid for this assay.The interpretation of results section of the atellica im tsh3-ul instructions for use (ifu) states: "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
Siemens filed the initial mdr 1219913-2023-00179 on aug 29, 2023.Additional information sep 06, 2023: an outside the united states customer obtained low quality control (qc) results and a discordant falsely depressed thyroid stimulating hormone 3-ultra (tsh3-ul) result for a patient sample, on atellica im 1600 analyzer.The initial result was not reported to the physician(s).The sample was repeated on an alternate atellica im analyzer, and the result was higher compared to the initial result.The higher result was considered as the correct result.The pack in question used a previously valid acceptable calibration.The most probable cause of the low control and patient result is a degradation of the pack in question due to light exposure.Light exposure will degrade the middle well fitc reagent which in turn causes low control and patient recoveries when using a calibration from a pack that is not degraded.No further investigation is required.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: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17640432
• Report Number: 1219913-2023-00179
• Device Sequence Number: 5970348
• Product Code: JLW
• UDI-Device Identifier: 00630414600178
• UDI-Public: 00630414600178
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/29/2023

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: 12/14/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995704
• Device Lot Number: 415
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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