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	06/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer service engineer (cse) was sent to the customer site for system inspection, performed a total service call, and found no system related issues.The cse performed a random sample (n = 10) precision check (2.1% cv), verified probe alignments, and quality controls were acceptable.The cause of the non-reproducible false low advia centaur tsh3-ultra ((tsh3-ul) result a patient sample is unknown.The patient sample is not available for further testing.No conclusion can be drawn.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 instrument is performing within specification.No further evaluation of the device is required.
Event or Problem Description
A false low advia centaur tsh3-ultra ((tsh3-ul) result was observed on a patient sample when the customer performed verification testing after quality control results were out of range due to a new reagent readypack placed on the system.It is the laboratory's protocol to repeat all tested samples from when qc was last acceptable to when qc was out of range.A calibration of tsh3-ultra assay was performed with the new reagent readypack placed on the system, and qc was acceptable.The patient sample was repeated and higher results were obtained.The patient sample was tested on an alternate advia centaur system and the result was higher than originally reported.A corrected report was issued.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.

• 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: 7681439
• Report Number: 1219913-2018-00180
• Device Sequence Number: 1398056
• Product Code: JLW
• UDI-Device Identifier: 00630414535654
• UDI-Public: 00630414535654
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K150403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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: 11/10/2018
• Device Model Number: N/A
• Device Catalogue Number: 10282379
• Device Lot Number: 114316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1