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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is investigating this issue.
Event or Problem Description
A discordant high cardiac troponin patient result was obtained on an advia centaur xp instrument.The initial result was reported to the physician(s).The same sample was repeated on the same instrument.The 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 results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2020-00130 on (b)(6) 2020.Additional information ((b)(6) 2020): the customer contacted the siemens customer care center (ccc) and a siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument.The cse inspected the luminometer dark counts, with and without cuvettes, and all were acceptable.Cse also checked the acid and base delivery, water and wash 1 delivery to wash manifold, and confirmed a cuvette bottom out for r2, ancillary, and sample probes.The cse found reagent probe alignments out of tolerance and adjusted them accordingly.The cse also replaced the guide follower block for reagent 1, 2, and 3 (r1, r2, r3) probes, the water reservoir, water system bottle, water pump, and the water bellows pump.System was fully functional upon departure.Siemens also reviewed the data provided and confirmed that the quality controls (qc) ran high at the time of the incident.The instrument is performing according to specifications.No further evaluation of this device is required.Section h6 has been updated to reflect the additional information.

• 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: 9678531
• Report Number: 2432235-2020-00130
• Device Sequence Number: 2667682
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1