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	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was dispatched to the customer's site to inspect the advia centaur xp instrument.The cse, in consultation with the siemens regional support center (rsc), replaced the sample dilutor probe, the wash displacement dilutor and checked the wash station.The cse ran the dry, wetwater and wetwash 1 protocols, the cse then cleaned the system with bleach.Siemens is investigating the issue.
Event or Problem Description
A discordant (b)(6) antibodies to (b)(6) patient sample test result was obtained from an advia centaur xp instrument.The initial test result was not reported to the physician(s).The same sample was repeated three times on the same instrument giving a (b)(6) test result each time.The (b)(6) test result is considered correct and was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the false (b)(6) test result.
Additional Manufacturer Narrative
Additional information (03-may-2018): a siemens customer service engineer (cse) reported that one of the dilutor pumps was broken and occasionally allowed air to enter the wash 1 line.The instrument was returned to an operational state by replacing the dilutor pump.The cause of the false positive anti-hepatitis b surface antigen antibodies (anti-hbs) was a broken dilutor pump.The instrument is performing according to specifications.No further investigation is required.The evaluation codes for result code and conclusion code were revised.

• 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: 7480916
• Report Number: 2432235-2018-00194
• Device Sequence Number: 18881181
• 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): 05/21/2018

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: 04/12/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1