MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TSH-3ULTRA (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	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant tsh3-ul results is unknown.Siemens healthcare diagnostics is investigating.Mdr 1219913-2019-00222 and mdr 1219913-2019-00223 were filed for the same event.
Event or Problem Description
A false low advia centaur xp tsh3-ultra (tsh3-ul) result was obtained for a patient sample compared to the clinical picture and the advia centaur xp tsh assay.There are no reports that treatment was altered or prescribed or adverse health consequences due to the low advia centaur xp tsh3-ultra result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2019-00221 on november 07, 2019.The customer complained of a discordant result on one patient sample in the advia centaur tsh3 ultra assay.Internal testing could not be performed because the patient sample could not be sent to siemens due to patient rights.The most likely cause of the low tsh3 ultra result for this patient sample is described in the limitations section of the advia centaur tsh3 ultra instructions for use (ifu): "as with any immuno-recognition measurement of a peptide, extremely rare genetic variants may exhibit varying degrees of detection".There is no product issue.The issue is sample specific.The customer requires no further support from siemens on this complaint.Mdr 1219913-2019-00222 supplemental report 1 and mdr 1219913-2019-00223 supplemental report 1 were filed for the same event.

• Brand Name: ADVIA CENTAUR XP TSH-3ULTRA (TSH3-UL)
• Common Device Name: TSH3-UL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9291255
• Report Number: 1219913-2019-00221
• Device Sequence Number: 1865133
• Product Code: JLW
• UDI-Device Identifier: 00630414535654
• UDI-Public: 00630414535654
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Followup
• Report Date (Section B): 11/21/2019

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: 03/10/2020
• Device Model Number: N/A
• Device Catalogue Number: 10282379
• Device Lot Number: 63203335
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1