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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was dispatched to the customer's site due to signal error messages on the advia centaur xp instrument.Upon multiple visits, the cse performed base line decontamination and replaced the base line manifold, base probe, acid pump head and acid line manifold.Then, the cse ran quality controls, which recovered within expected ranges.During the cse visit on 30-mar-2018, the customer reported that a discordant, falsely low thcg result was obtained on a patient sample on (b)(6) 2018.Siemens further investigated the event and determined that acid or base dispense issues potentially contributed to the discordant thcg result and these issues were resolved during the cse visits.The cause of the discordant, falsely low thcg result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low total human chorionic gonadotropin (thcg) result was obtained on a patient sample on the advia centaur xp instrument.The initial result was reported to the physician(s), who questioned the result.The same sample was rerun, at multiple dilutions, on an alternate advia centaur instrument, resulting higher.The 3rd repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low thcg result.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7441102
• Report Number: 2432235-2018-00163
• Device Sequence Number: 11020528
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K971418
• 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
• Report Date (Section B): 04/18/2018

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 Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 10471899
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR