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

Model Number	ADVIA CENTAUR CP ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely elevated total human chorionic gonadotropin (thcg) result was obtained for one patient sample when processed on an advia centaur cp analyzer.The initial elevated result was reported to the physician and was questioned.The same sample was reprocessed on the original analyzer and obtained a lower result.The lower result was considered correct since it matched the clinical history of the patient and was issued on the corrected report to the physician.For troubleshooting purposes, a new sample was drawn from the patient and tested on an alternate advia centaur xp instrument and obtained a similar lower result.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated thcg result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated total human chorionic gonadotropin (thcg) result was obtained for one patient sample when processed on an advia centaur cp analyzer.Quality control (qc) recovered within the laboratory established ranges prior to patient sample testing.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse inspected the analyzer, reviewed data and error log, replaced the blue and grey tubing, wash block and rinse block assembly and performed realignment of the probes.The cse performed precision study with qc and patient samples, which recovered acceptably.Siemens further evaluated the event and determined that issues with cuvette washing could potentially lead to falsely elevated thcg result.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR CP ANALYZER
• Common Device Name: ADVIA CENTAUR CP ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; neuwiesenstrasse 4; registration #: 3008494306; beringen 8222 ; SZ 8222
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21907543
• Report Number: 2432235-2025-00121
• Device Sequence Number: 8728998
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: (01)00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/25/2025

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 CP ANALYZER
• Device Catalogue Number: 10309710
• 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: 04/01/2025
• Initial Report FDA Received Date: 04/25/2025
• 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: Female