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	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) 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.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 and performed a total service visit.During the visit, the cse inspected the analyzer, reviewed data and error log and checked for leak, dark count, aspirate and dispense.Subsequently, the cse replaced the sample probe, sample syringe, and wash 1 pump and primed the analyzer.The cse performed precision study with patient samples and ran quality control (qc) which recovered acceptably.Return of the patient samples for further investigation is not warranted because the discordant results were not reproducible.Following this routine troubleshooting intervention, the issue was resolved although a specific cause for this event was unable to be determined.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a falsely elevated total hcg (thcg) result was obtained on one patient sample when processed on an advia centaur cp analyzer, serial number (s/n): (b)(6).The initial elevated result was reported to the physician.The elevated was questioned by the physician since the patient was not expected to be pregnant.The same sample was then reprocessed on the original and an alternate analyzer (advia centaur xpt) which produced lower results.The lower results were considered correct and the lower result obtained on the alternate analyzer was issued on the corrected report to the physician.Additionally, the patient was also tested for a urine hcg which obtained a negative result.There are no known reports of patient intervention or adverse health consequences due to the elevated thcg result.

• 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: 22780633
• Report Number: 2432235-2025-00208
• Device Sequence Number: 8176474
• 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): 08/12/2025

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: 07/17/2025
• Initial Report FDA Received Date: 08/12/2025
• 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