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	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant tsh3-ultra result is possibly the rare variant of tsh.Siemens healthcare diagnostics is investigating.The ifu states in the interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "as with any immuno-recognition measurement of a peptide, extremely rare genetic variants may exhibit varying degrees of detection." mdr 1219913-2019-00007 was 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.The result was considered discordant with the tsh assay.The result was higher for tsh.The sample was also tested on an alternate method and the result was higher than the tsh3-ultra result.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences due to the discordant tsh3-ultra result.
Additional Manufacturer Narrative
Siemens filed the initial mdr on (b)(6) 2019.01/28/2019 additional information: the most likely cause of the discordant results is the undetectable tsh due to the tsh variant that is described in important product safety information document #(b)(4) published in may 2013.The customer understands this and requires no further support from siemens on this event.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00007 supplemental report 1 was filed for the same event.

• 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 10591 5097
• MDR Report Key: 8271147
• Report Number: 1219913-2019-00006
• Device Sequence Number: 11283042
• Product Code: JLW
• UDI-Device Identifier: 00630414535654
• UDI-Public: 00630414535654
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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): 02/13/2019

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: 03/16/2019
• Device Model Number: N/A
• Device Catalogue Number: 10282379
• Device Lot Number: 319
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1