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

Model Number	ADVIA CENTAUR XP ANALYZER
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) to report that there was an ancillary queue loop out of tolerance thermal error with a burning smell from the ancillary queue area of the advia centaur xp analyzer, which caused a delay in testing.Siemens aided the customer in resetting the thermals and rebooting the analyzer.However; the issue persisted.The customer removed the reagents from the system, covered the reagents with parafilm and stored them in a refrigerator.The customer turned off the system.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer.Siemens is investigating.
Event or Problem Description
The customer observed an ancillary queue loop out of tolerance thermal error and a burning smell from the ancillary queue area of the advia centaur xp analyzer, causing a delay in testing patient samples.There are no known reports of patient intervention or adverse health consequences due to the delay.
Additional Manufacturer Narrative
The initial mdr 2432235-2022-00300 was filed on 15-nov-2022.Additional information (15-dec-2022): a siemens customer service engineer (cse) replaced a thermoelectric device (ted) assembly and an uninterruptible power supply (ups).The cse rebooted the system and verified proper ancillary temperature.The cse replaced and aligned reagent probe 3 and handed the system to the customer to run calibration and quality controls (qc).The customer performed calibration and qc with no issues.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.

• Brand Name: ADVIA CENTAUR XP ANALYZER
• Common Device Name: ADVIA CENTAUR XP ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING; registration #: 8020888; chapel lane; swords, co, dublin, 10040 ; EI 10040
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 15798354
• Report Number: 2432235-2022-00300
• Device Sequence Number: 4674324
• Product Code: JJE
• UDI-Device Identifier: 00630414585475
• UDI-Public: 00630414585475
• 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
• Report Date (Section B): 12/22/2022

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 ANALYZER
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2015
• 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