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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The quality controls were within acceptable ranges.A siemens customer service engineer (cse) was dispatched to the customer site.The cse tightened reagent probe 1 and 3 which were loose and checked the alignments of the sample probe and ancillary probes.The cse realigned the sample probe which was hitting the bottom of the cuvette.Quality controls were run and passed.The cause of the discordant, total human chorionic gonadotropin result is unknown.Based on the available data the event was potentially caused by the loose reagent probes or the alignment of the sample probe.The instrument is operating within manufacturing specifications.No further evaluation of the device is required.Siemens also filed mdr# 2432235-2019-00051 for this event.
Event or Problem Description
A discordant, falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an advia centaur xp instrument.The repeat result was discordant but was not reported to the physician(s).The sample was repeated multiple times.The result of 48.0 miu/ml was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated thcg result.

• 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: 8322254
• Report Number: 2432235-2019-00052
• Device Sequence Number: 16525765
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/08/2019

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: 01/14/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1