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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the advia centaur xp instrument displayed cuvette pusher offline error.While troubleshooting, the operator scratched their hand while opening the cover of the instrument.The operator was wearing personal protective equipment (ppe) while troubleshooting the instrument.The operator immediately disinfected the scratch with water and soap and continued the troubleshooting wearing gloves.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
The united states (us) customer contacted the siemens customer care center (ccc) and reported that the advia centaur xp instrument displayed cuvette pusher offline error.While troubleshooting, the operator scratched their hand while opening the cover of the instrument.Siemens remotely assisted the customer turned off the instrument, opened instrument cover, removed cuvettes through the cuvette¿s pathway which includes the preheater assembly, cuvette chute, ring loader and elevator, closed the cover, turned on the instrument, homed system and performed empty and fill ring.Siemens further evaluated the event and determined that mechanical obstructions caused by the cuvettes potentially contributed to the event.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 19382827
• Report Number: 2432235-2024-00112
• Device Sequence Number: 17090112
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: 00630414573564
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2024
• Initial Report FDA Received Date: 05/23/2024
• Date Device Manufactured: 03/23/2015
• 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: Unknown