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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc).The ccc specialist was made aware that quality control (qc) results were within specifications and no error messages were generated by the instrument.A siemens customer service engineer (cse) was dispatched to the customer's site.Siemens is investigating the issue.
Event or Problem Description
The customer informed siemens of (b)(6) discordant results obtained on the advia centaur xp instrument.The discordant results were not reported to the physician(s).The customer used the same sample and instrument to perform repeat testing.Repeated test results were lower (nonreactive), and the customer stated that results did not match previous results.The customer did not provide additional information, and it is unknown if discordant results are (b)(6) or (b)(6).There are no reports of patient intervention or adverse health consequence due to the discordant (b)(6) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2018-00313 on 30-july-2018.Additional information received on 03-august-2018: siemens has been following up with the customer.The customer stated that the discordant results were due to an issue with their laboratory information system (lis).The customer informs the lis has been fixed and no longer an issue.No further assistance requested.No further evaluation of this device is required.Results code and conclusions code were updated.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7733311
• Report Number: 2432235-2018-00313
• Device Sequence Number: 2542523
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 08/28/2018

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
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1