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

Model Number	ADVIA CENTAUR CP ANALYZER
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) that falsely depressed total human chorionic gonadotropin (thcg) results were obtained on a patient sample on an advia centaur cp analyzer.Quality control (qc) was within range prior running the patient samples.The siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, aligned the sample probe to the incubation ring, and replaced the sample probe syringe.Then, the cse performed a precision study for two different qc samples.Further, the cse replaced the sample diluter pump and ran three separate qc samples, which recovered as expected.Siemens further evaluated the event and concluded that the issue with sample probe potentially contributed to the reported event.The instrument was performing within specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that falsely depressed total human chorionic gonadotropin (thcg) results were obtained on a patient sample on an advia centaur cp analyzer.The first auto diluted result was reported to the physician(s), who questioned the result.The sample was repeated thrice on the original analyzer, similar results were obtained and considered erroneous.The sample was repeated on an alternate advia centaur cp analyzer.The repeat result obtained was higher and reported as correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed thcg results.

• 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: 22201429
• Report Number: 2432235-2025-00149
• Device Sequence Number: 20519718
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: (01)00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/13/2025

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: 05/20/2025
• Initial Report FDA Received Date: 06/13/2025
• 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