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	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to inform of signal errors and discordant results.Siemens dispatched a customer service engineer (cse) to the customer site.The cse performed troubleshooting and completed a total service check on the advia centaur xp system.The cse noted the user interface (ui) failed to reboot and replaced the ui assembly.Siemens is investigating the event.
Event or Problem Description
The customer informed siemens of discordant falsely elevated alpha-fetoprotein (afp) results obtained on the advia centaur xp instrument.The results were not reported to the physician(s).The customer used the same patient samples and an alternate advia centaur to perform repeat testing.The customer noted the repeat results were lower and considered to be correct results.There are no reports of patient intervention or adverse health consequences due to the falsely elevated afp results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2021-00246 on 11-oct-2021.Additional information (23-dec-2021): siemens reviewed the instrument and event data and noted the siemens customer service engineer (cse) performed several troubleshooting steps on the advia centaur xp instrument, including checking dark counts, checking valve operation and tubing, cleaning the luminometer, and serviced the user interface (ui).Siemens verified the instrument's performance and noted that calibrators and quality control (qc) were performed, and patient samples ran successfully.Siemens verified that the laboratory information system (lis) transferred a sample id correctly and noted the sample results for a re-run compared well with other advia centaur results.The operation of the instrument was successful.Siemens completed the investigation and concluded that the cause of discordant falsely elevated alpha-fetoprotein (afp) results is unknown and cannot rule out pre-analytical factors or a sample-related issue.The advia centaur xp instrument operates as specified and requires no further evaluation.Siemens updated section h6 (investigation findings and investigation conclusions) to include a new code.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane; registration number: 8020888; swords, co., dublin ; EI
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591
• MDR Report Key: 12611516
• Report Number: 2432235-2021-00246
• Device Sequence Number: 13793398
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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: 09/17/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2010
• 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