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

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	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was dispatched to the customer site.The cse checked the valves, distribution of probe dilutors and functioning of the aspirate, reagent and ancillary probes.The cse replaced and verified the alignments of the reagent 1, reagent 2 and ancillary probes.The cse greased the associated parts of probes and cleaned the injection port 2.The cse found leak on the water line of the base pump.The cse replaced the silicon tubing and adjusted the vacuum.The cse ran calibration and quality control, which were acceptable.The cause of the discordant, false reactive toxo g result on one patient sample is unknown.The device is performing within manufacturing specifications.No further evaluation of device is required.
Event or Problem Description
A discordant, false reactive result for assay for the detection of igg antibodies to toxoplasma gondii (toxo g) was obtained on one patient sample on an advia centaur xp instrument.The discordant result was reported to the physician(s).The patient was tested in another laboratory and the result for toxo g was nonreactive.The patient questioned the initial result and the customer repeated the sample on the same instrument, which resulted nonreactive.The nonreactive result was reported as a correct result to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, false reactive toxo g result.
Additional Manufacturer Narrative
The initial mdr 2432235-2018-00202 was filed on 02-may-2018.Additional information (14-may-2018): a siemens headquarters support center (hsc) specialist reviewed the sample handling data and determined that it was in accordance with the advia centaur igg antibodies to toxoplasma gondii (toxo g) instructions for use.The hsc specialist determined that the customer's calibration and quality control (qc) for toxo g were within ranges and comparable with release data.The hsc specialist concluded that the potential cause of the discordant toxo g result was due to the presence of particulate matter in the sample.The calculated specificity at the customer site for toxo g assay on advia centaur xp instrument was 99.9%.The relative specificity results from the 3 studies in the advia centaur toxo g ifu ranges from 99.3% - 99.8%.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7479822
• Report Number: 2432235-2018-00202
• Device Sequence Number: 10811609
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 06/06/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR