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	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an initial reactive antibodies to 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).The sample was repeated in duplicates on the original instrument and results recovered as reactive and non-reactive respectively.Then, the customer repeated the sample on an alternate advia centaur xp instrument and results recovered as non-reactive.The repeat non-reactive results were considered correct and were reported to the physician(s).There is no known reports of patient intervention or adverse health consequences due to an 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 antibodies to 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 inspected the instrument, replaced the aspirate tube, repositioned, and secured the grounding cable on aspirate 4, performed dispense and aspirate test with water and wash on each probe, and ran 4 ahbs2 patients five times, which recovered acceptably.Then, the cse determined the multiple qc with signal 1 errors, repositioned the acid and aspirate tubing to avoid crimping, performed dispense tests, which passed.Next, the cse reran all qc, readjusted the aspirate probe tubing into sleeves and performed the aspirate and dispense tests again, which recovered acceptably.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2024-00257 on 25-oct-2024.Additional information (29-oct-2024): in addition to the service activities mentioned in the initial report, the siemens customer service engineer (cse) performed a total service visit, calibrated, and adjusted reagent probes 1, 2, and 3, verified acid and base dispenses and aspirations on all aspirate probes, verified dark counts and ran quality control (qc), which recovered acceptably.Siemens further evaluated the event and determined that an instrument malfunction, which was addressed with the service activities performed by the cse, contributed to the initial reactive results.The service activities and the routine troubleshooting actions performed by the cse, as described in the initial report, resolved the issue.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, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20532057
• Report Number: 2432235-2024-00257
• Device Sequence Number: 15113531
• 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,Followup
• Report Date (Section B): 11/15/2024

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: 10/08/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2016
• 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