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
Event or Problem Description
The customer reported that erroneously depressed total human chorionic gonadotropin (thcg) results with an over-pressure error message were obtained on a patient sample on an advia centaur cp analyzer.Initially, the customer ran the patient sample and received an over-pressure error.The sample was auto-repeated and obtained a above the assay range result.Subsequently, the sample was auto-diluted, which again resulted in an over-pressure error.The auto-diluted result was reported to the physician(s), who questioned the result.Then the sample was repeated thrice on the original analyzer, and the results recovered higher than the auto-diluted result with over-pressure error.The sample was repeated a second time on an alternate advia centaur cp analyzer, and the result recovered higher than the auto-diluted result without an over-pressure error.The repeat result obtained on the alternate analyzer 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 erroneously depressed thcg results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneously depressed total human chorionic gonadotropin (total hcg) result with an overpressure error message were obtained on a patient sample on an advia centaur cp analyzer.Quality control (qc) was acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer site.During the visit, the cse inspected the system, replaced the sample probe air pump assembly and sample air diluter.The cse verified the sample probe pressure, which was within the range, and five times precision tests with and without dilution, and no over-pressure errors were observed.Further, the cse ran qc, which recovered acceptably.Siemens evaluated the event and determined that the sample air diluter potentially contributed to the erroneously depressed total hcg results.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: 22165552
• Report Number: 2432235-2025-00145
• Device Sequence Number: 13111922
• 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): 06/09/2025

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: 05/18/2025
• Initial Report FDA Received Date: 06/09/2025
• 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