MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; IMMUNOASSAY ANALYZER

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that luminometer errors were triggered by the advia centaur xp instrument.A siemens customer service engineer (cse) was dispatched to the customer's site multiple times.After inspecting the instrument, the cse: cleaned and inspected the luminometer; replaced the acid and base pumps, valve and tubing; primed the acid line; ran a dispense tests for the acid/base pump, dark counts, and quality controls (qcs), and all the tests and qcs recovered acceptably.There were no other luminometer errors noted post service.The malfunctioned acid/base pumps potentially contributed to the discordant thyroid-stimulating hormone 3-ultra (tsh3-ul) and free triiodothyronine (ft3) results.The instrument is operating within manufacturing specifications.No further evaluation of the device is required.
Event or Problem Description
The customer reported that discordant thyroid-stimulating hormone 3-ultra (tsh3-ul) and free triiodothyronine (ft3) results were obtained on multiple patient samples on an advia centaur xp instrument.The discordant results were reported to the physician(s), and some physician(s) questioned the results.The customer provided the discordant, falsely low tsh3-ul result obtained on one patient sample.The customer reported that based on the discordant, falsely low tsh3-ul result, the patient was diagnosed with grave's disease and was prescribed medication.The sample was repeated on an alternate advia centaur instrument, resulting higher.The repeat result was reported, as the correct result, to the physician(s), and the medication order was cancelled.The customer did not provide the test results obtained on the other patient samples, but indicated that some results needed to be corrected.There are no reports of patient intervention or adverse health consequences due to the discordant tsh3-ul and ft3 results.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8601833
• Report Number: 2432235-2019-00167
• Device Sequence Number: 2011188
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K971418
• 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): 05/10/2019

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 Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1