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	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quality control (qc) recovered out of range overnight at the time the discordant results were generated.The customer discarded the reagent pack onboard the instrument, loaded a fresh reagent and ran calibrators and qc which recovered within range.Repeat results were generated after qc recovered within range.The customer did note that calibrator vials received from the lab's warehouse were not completely sealed.The customer service engineer (cse) went onsite.Calibrators, qc, and a precision study were run, and all passed.The cse provided an explanation of the difference between a pack calibration versus a lot calibration to the customer.Siemens confirmed with the customer that the readypacks are stored in the boxes in the refrigerator.Siemens continues to investigate.
Event or Problem Description
Discordant, falsely depressed thyroid stimulating hormone 3-ultra (tsh3 ul) results were obtained on patient samples on an atellica im 1300 (s/n: (b)(4)) instrument.The falsely depressed results were reported to the physician(s).The samples were repeated on the same instrument, generating higher results which were reported to and accepted by the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed tsh3 ul results.
Additional Manufacturer Narrative
Mdr 1219913-2021-00334 was filed on june 3, 2021.June 14, 2021 - additional information the customer stated they got discordant low patient results on one readypack only of atellica tsh3-ultra reagent lot 373.On the same readypack controls were low out of range.Internal testing could not be performed as the customer discarded the one problematic readypack.The most likely cause of the low qc and patient results is light exposure to the readypack in question.Light exposure will degrade the middle well reagent which in turn will cause low recoveries on patients and qc.The storage and stability section of the instructions for use states: "protect the product from heat and light sources." there is no systemic product problem.The customer moved to a new readypack of lot 373 and qc and patient results were acceptable.The customer is currently running the assay and requires no further support from siemens on this complaint.The investigation findings and investigation conclusions codes have been updated in section h6.

• 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
• MDR Report Key: 11929516
• Report Number: 1219913-2021-00334
• Device Sequence Number: 3831456
• Product Code: JLW
• UDI-Device Identifier: 00630414600161
• UDI-Public: 00630414600161
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 02/17/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995703
• Device Lot Number: 373
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1