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

Model Number	ADVIA CENTAUR XP IMMUNOASSAY SYSTEM
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens customer care center (ccc) and reported that erroneous cancer antigen 27.29 (br 27.29) results were obtained on 12 patient samples on an advia centaur xp immunoassay system.The quality control (qc) was in range on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse performed a total service visit (tsv) and found that dilution probe 2 (dp2) failed to dispense water.The cse replaced the dp2 valves, retested the dp2 dispense, which was acceptable, and re-primed the system wash block.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that erroneous cancer antigen 27.29 (br 27.29) results were obtained on 12 patient samples on an advia centaur xp immunoassay system.The erroneous results were reported to the physician(s).The samples were repeated on an original system.The repeat results were considered correct and reported to the physician(s).The customer did not provide the specific patient results data to siemens.There are no known reports of patient intervention or adverse health consequences due to the erroneous br 27.29 results.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2024-00366 on 31-dec-2024.Additional information (23-jan-2025): siemens has received patient results data for all impacted patient samples.The sections a1, b5, b6 and medical device problem code in section h6 were updated to reflect the patient results data.Correction (23-jan-2025): the 'date of event' in the initial report was selected as (b)(6) 2024.Based on the additional information received, section b3 was updated with the correct "date of event".
Event or Problem Description
The customer reported that falsely depressed cancer antigen 27.29 (br 27.29) results were obtained on four patient samples on an advia centaur xp immunoassay system.The erroneous results were not reported to the physician(s).The samples were repeated on an original system.The repeat results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated br 27.29 results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00366 on 31-dec-2024 and the first supplemental mdr on 2432235-2024-00366_s1 on 11-feb-2025.Additional information (21-mar-2025): with the service performed, it was identified that the dispense port 2 (dp2) in the instrument could have potentially caused the elevated results.This issue was resolved by standard service actions.The investigation conclusion code in the h6 section was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XP IMMUNOASSAY SYSTEM
• Common Device Name: ADVIA CENTAUR XP IMMUNOASSAY SYSTEM
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21046515
• Report Number: 2432235-2024-00366
• Device Sequence Number: 3417344
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: (01)00630414573564
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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 IMMUNOASSAY SYSTEM
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 01/23/2025; 03/21/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/11/2025; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2019
• 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