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	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated vitamin b12 (vb12) result was generated on a patient sample on an advia centaur xp instrument.The erroneous result was reported to the physician(s).The patient sample was repeated on the same instrument and recovered lower than the erroneous result.The customer was confident with repeat result as it correlated with the results retested at other reference lab and other branch of same center.The repeat result was reported to the physician(s), as the correct result.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated vb12 result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report that a falsely elevated vitamin b12 (vb12) result was generated for a patient sample on an advia centaur xp instrument.Quality controls were in range at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse performed sample and reagent probe alignments, cleaned all reservoirs, performed a decontamination, checked aspirate, and dispense ports for any drift, and checked acid and base probe dispense volume.On a subsequent visit, the cse performed a decontamination again, reverified reagent probe, sample probe and ancillary probe alignments, and primed system 4 times.Then the cse checked the dispense port and aspirate probe down alignments, the acid, base priming and verified the volumes.Next the cse changed the reagent probe 1 and 2 valves and replaced ancillary and four aspirate probes.The cause of the falsely elevated vb12 result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed initial mdr 2517506-2023-00097 on 17-mar-2023.Additional information (23-mar-2023): the initial report indicates "the customer was confident with repeat result as it correlated with the results retested at other reference lab and other branch of same center".The customer provided the result obtained at the reference laboratory.The instrument and assay used at the other laboratory are unknown.Additionally, the customer provided the gender of the patient.Furthermore, a precision study was performed on patient samples.Sections a3 and b6 were updated with this information.The instrument is performing according to specifications.No further evaluation of this device is required.

• 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: douglas stanton ; 511 benedict ave; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 16567845
• Report Number: 2517506-2023-00097
• Device Sequence Number: 12152771
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/14/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2011
• 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