MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT TSH3-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	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a discordant, falsely depressed thyroid stimulating hormone result for the advia centaur xpt tsh3-ultra (tsh3-ul) assay when compared to the patient's clinical picture and repeat results from the same sample.The patient is being treated for hyperthyroidism.The initial advia centaur xpt tsh3-ul result was reported to the physician who questioned the depressed result.A corrected report was issued.There are no reports that treatment was altered or prescribed or adverse health consequences due to the depressed advia centaur xpt tsh3-ul result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report discordant, falsely depressed advia centaur xpt tsh3-ultra (tsh3-ul) patient results compared to the repeat results from the same sample.Calibrations and quality control (qc) were acceptable.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
Siemens filed mdr 1219913-2022-00059 initial report on 17-feb-2022.Additional information - 22-march-2022.An outside the us customer stated they observed a discordant result on the advia centaur xpt tsh3 ultra assay on one pediatric patient sample on initial testing.The initial result did not match the historical value.The correct result was obtained on repeat testing performed 20 hours later and again after 20 hours and 15 minutes.The repeat testing results match the historical result.The customer stated qc results were in range for the assay.Pre-analytical issues cannot be ruled out as the probable cause.Internal testing could not be performed as there was no sample volume left for testing.There is no product problem.Customer is operational and no further action required.

• Brand Name: ADVIA CENTAUR XPT TSH3-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 memishian ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13551903
• Report Number: 1219913-2022-00059
• Device Sequence Number: 5187113
• Product Code: JLW
• UDI-Device Identifier: 00630414535654
• UDI-Public: 00630414535654
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/19/2022

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: 05/25/2022
• Device Model Number: N/A
• Device Catalogue Number: 10282379
• Device Lot Number: 378
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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 Age: 4 YR
• Patient Sex: Female