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

Model Number	ADVIA CENTAUR XP ANALYZER
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an initial reactive anti-hepatitis b surface antigen (ahbs2) result was obtained on a patient sample on the advia centaur xp analyzer.The initial reactive result was not reported to the physician(s).Initially, the customer repeated the sample in duplicates on the original instrument and the results recovered as reactive and non-reactive.Then, the customer repeated the same sample on both the original and alternate advia centaur xp instruments and the results recovered as non-reactive.The repeat non-reactive result was considered correct and was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the initial reactive ahbs2 result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that an initial reactive anti-hepatitis b surface antigen (ahbs2) result was obtained on a patient sample on the advia centaur xp analyzer.Quality control (qc) and calibration recovered acceptably on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse determined low water volume at dispense port 3, dilution probe (dp3) diluter had a sensor that was not detected within the allowed range during the homing of reagent 3 diluter.The cse pumped water through the fluidics manifold and verified that there was no blockage.The cse observed failed daily cleaning procedure (dcp), replaced diluter, ribbon cable, 2-way valves 14, 17, 15, 16, 76 and 3-way valves 54 and 55, base fluids cable, and aspirate tubing.The cse repositioned and secured the grounding cable on aspirate 4, performed a dispense/aspirate test with water and washed on each probe, and ran 4 ahbs2 patients five times which recovered acceptably, repositioned the acid tubing and aspirate tube, readjusted the aspirate probe tubing into the sleeves, and performed the dispense and aspirate tests, which recovered acceptably.The cse calibrated and performed slight changes to reagent probes 1, 2, and 3, verified aspirate probes for dispenses and aspirations, which recovered acceptably; verified dark counts and acid and base dispenses and ran qc, which recovered acceptably.Siemens has determined that there were no issues with the reagent as qc recovered within acceptable ranges, and no issues were reported with other patient samples.Siemens evaluated the event and determined that an instrument malfunction, which was addressed with the service activities performed by the cse, potentially contributed to the initial reactive (ahbs2) results.The instrument is performing according to specifications.No further evaluation of this device is required.

• 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 LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: mekala g ; pritech park sez, block11; sarjapur outer ring road; karnataka 10591 ; IN 10591 ; 840457474
• MDR Report Key: 20459716
• Report Number: 2432235-2024-00231
• Device Sequence Number: 18084032
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: (01)00630414573564
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/16/2024

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 ANALYZER
• 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: 09/27/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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