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

Model Number	ADVIA CENTAUR XP ANALYZER
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated total human chorionic gonadotropin (thcg) results were obtained on 12 patient samples on an advia centaur xp analyzer.The erroneous results were reported to the physician(s).The samples were repeated on an alternate advia centaur analyzer.The repeat results were lower than the erroneous results.The repeat results were reported, as the correct results, to the physician(s).The customer also reported a result of 31.6 miu/ml was obtained on another patient sample, which was reported to the physician and not corrected, although the sample recovered higher when the customer reprocessed the sample.There are no known reports of patient intervention or adverse health consequences due to the erroneous thcg results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report erroneous total human chorionic gonadotropin (thcg) results were obtained on 13 patient samples on an advia centaur xp analyzer.Quality controls (qcs) recovered within ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.Through instrument files, siemens determined that at the time of the event, probe 1 was offline and the instrument produced a volume check error due to the unavailability of the reagent.During this visit, the cse inspected the instrument and checked for leaks; the cse did not identify any leaks and determined that the instrument required lubrication.The cse lubricated the sample probe dilutor, the syringe and the bearings responsible for the probe¿s vertical movement, cleaned the luminometer, and ran several tests to confirm the proper functioning of the equipment, including wash 1, water, and base dispensing tests and an aspiration test, which recovered acceptably.The cse also attempted to run an acid dispensing test.The acid dispensing test did not initiate.Thus, the cse replaced the acid pump.Next, the cse ran qc¿s and calibrations, which recovered acceptably.Siemens further evaluated the event and concluded instrument related issues, such as sample probe malfunctions, potentially contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XP ANALYZER
• Common Device Name: ADVIA CENTAUR XP ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane; registration number: 8020888; swords, co. ; EI
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 21027048
• Report Number: 2432235-2024-00363
• Device Sequence Number: 8191561
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: (01)00630414573564
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K041133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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 ANALYZER
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female