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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Codes	Use of Device Problem (1670); Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) to report erroneous vitamin b12 (vb12) patient results were generated on an advia centaur xp analyzer.The quality controls (qc) were acceptable prior to the event; however, after processing the patient samples were unacceptable.Siemens remotely assisted the customer to resolve an incubation ring offline error which occurred as the customer was repeating the samples.Upon siemens recommendation, the customer turned the mechanics off and found no cuvettes were jammed in the cuvette pathway.The customer turned on the mechanics and performed the empty/ fill procedure.The samples were repeated successfully, and these results provided to the physician(s).The customer further investigated and found that the dithiothreitol (dtt) fluid used for this assay to generate the initial results and the unacceptable qc was made up by the user with the incorrect amounts.The issue was resolved when the user made new dtt fluid with the correct amounts and reprocessed the samples.Siemens ruled out reagent issues as the potential cause based on a review of qc which showed recovery within acceptable ranges when the dtt ancillary was prepared according to the instructions for use.Siemens concluded that a self-identified operator error contributed to the erroneous vitamin b12 results.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that multiple erroneous vitamin b12 (vb12) patient results were generated on an advia centaur xp analyzer.The customer had just made up new dithiothreitol (dtt) solution for the assay prior to processing the quality controls (qc) and processing these samples.The customer questioned all the results as the qc the following morning was unacceptable and did not report them to the physician(s).The next day, the customer made up new dtt solution, recalibrated the assay and processed qc successfully.Then, the customer repeated the samples and considered all those results correct, which they reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous vb12 results.

• 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, swords co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: douglass stanton ; 511 benedict ave.; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 19386481
• Report Number: 2432235-2024-00114
• Device Sequence Number: 6875879
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: 00630414573564
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 05/08/2024
• Initial Report FDA Received Date: 05/23/2024
• Date Device Manufactured: 03/19/2018
• 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