MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL); TSH3-UL IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report discordant, falsely low advia centaur tsh3-ultra (tsh3-ul) results obtained on patient samples.Siemens has reviewed the information provided.The advia centaur tsh3-ultra (tsh3-ul) assay uses different antibodies than the centaur tsh3 ultra assay.The advia centaur tsh result of 3.0 uiu/ml and the data evaluated suggests a genetic variant is present in both samples.The instruction for use (ifu) in the limitation section states the following: "as with any immuno-recognition measurement of a peptide, extremely rare genetic variants may exhibit varying degrees of detection." based on the investigation, a product performance issue is not confirmed.No further evaluation of the device is required.Mdr 1219913-2020-00059 (sample 1) was filed for the same event.
Event or Problem Description
Falsely low advia centaur tsh3-ultra (tsh3-ul) results were obtained on patient samples.The results were considered discordant compared with the tsh assay result, and the results obtained from other alternate tsh test methods.The customer indicated that historically, the advia centaur tsh3-ultra results have been low.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences due to the discordant tsh3-ultra results.

• Brand Name: ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL)
• Common Device Name: TSH3-UL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9711594
• Report Number: 1219913-2020-00060
• Device Sequence Number: 11631622
• Product Code: JLW
• UDI-Device Identifier: 00630414535654
• UDI-Public: 00630414535654
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K150403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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: 05/05/2020
• Device Model Number: N/A
• Device Catalogue Number: 10282379
• Device Lot Number: 97437340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1