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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to inform that a patient sample was falsely elevated (>11010 pmol/l) for enhanced estradiol (ee2).Siemens is investigating the event.
Event or Problem Description
The customer observed a false elevated enhanced estradiol (ee2) result on an advia centaur xp instrument.The result was not reported to the physician(s).The customer used the same sample to perform repeat testing on an alternate advia centaur xp instrument and observed a lower result.The customer noted that repeat result was correct based on the performance of the alternate instrument, clinical details, and other tests performed.The correct result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the false elevated ee2 result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2021-00104 on 05-may-2021.Additional information (09-jun-2021): siemens reviewed the information provided and verified that the attending cse performed a thorough inspection of the affected instrument, reagent probe calibrations, replaced the wash separation manifold, and 3-way valves associated with the daily cleaning procedure.Siemens determined that services are complete, and the cause of a false elevated enhanced estradiol (ee2) result is unknown.The advia centaur xp instrument is performing within specifications and required no further evaluation.Siemens updated section h6 to include new codes for investigation findings and investigation conclusions.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 11779738
• Report Number: 2432235-2021-00104
• Device Sequence Number: 11748803
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K041133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 06/25/2021

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: 04/13/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1