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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant low advia centaur xp tsh3-ultra result is unknown.Siemens is investigating.The instruction for use (ifu) states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instruction for use (ifu) states in the limitation section: "as with any immuno-recognition measurement of a peptide, extremely rare genetic variants may exhibit varying degrees of detection.".
Event or Problem Description
A false low advia centaur xp tsh3-ultra ((tsh3-ul) result was obtained by the customer, and the result was questioned by the clinician.The patient sample was tested for tsh on the advia centaur xp, and the result was normal.The patient sample was sent to another laboratory, tested for tsh on an alternate test method (siemens immulite), and the result was normal.The patient sample was repeated at the original laboratory on a second alternate tsh test method, and the result was normal.The customer performed repeat tsh3-ul testing of the patient sample and the result was low.The alternate tsh test method results were reported to the physician.There was no report of patient treatment being prescribed or altered, or adverse health consequences due to the discordant advia centaur xp tsh3-ultra result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00189 on 08/31/2017 for a false low advia centaur xp tsh3-ultra ((tsh3-ul) patient result.09/06/17 - additional information: the patient sample is not available for further testing.Based on the information provided, and without having the sample to test, the likely cause of the discordant result may be attributed to a tsh variant.The instruction for use (ifu) states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instruction for use (ifu) states in the limitation section: "as with any immuno-recognition measurement of a peptide, extremely rare genetic variants may exhibit varying degrees of detection." the instrument is performing within specifications.No further evaluation of the device is required.

• 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: 6835646
• Report Number: 1219913-2017-00189
• Device Sequence Number: 13467864
• Product Code: JLW
• UDI-Device Identifier: 00630414535647
• UDI-Public: 00630414535647
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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: 11/14/2017
• Device Model Number: N/A
• Device Catalogue Number: 10282378
• Device Lot Number: 114297
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1