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

Model Number	ADVIA CENTAUR CP
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report issues with quality control (qc) recoveries for the progesterone (prge), total human chorionic gonadotropin (total hcg), and enhanced estradiol (ee2) assays on the advia centaur cp instrument.The customer subsequently reported that when they processed a sample for prge twice on the advia centaur cp instrument, the repeat result did not correlate to the initial result.Prge qc recoveries were acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse verified proper levels of dispense for the acid and base pumps and performed a total service visit.Next, the cse, checked the acid base volume, the wash station dispenses and aspiration, the sample probe, reagent probe, and the wash blocks.Then, the cse replaced a wash block, cleaned the luminometer, replaced the waste pump membrane, primed the instrument, and ran successful precision studies for hcg and prge.In a subsequent visit, the cse replaced the gray peristaltic pump tubing and the waste internal tubing and primed the system successfully.Next, the customer ran a successful precision study for each assay and tested the prge master curve material, which recovered acceptably.Then, the customer ran qc for all three assays, 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.
Event or Problem Description
The customer reported that a progesterone (prge) result of 6.0 ng/ml was generated on a patient sample on an advia centaur cp instrument.This result was not reported to the physician(s).The sample was repeated on the same instrument and recovered lower than the initial result.Subsequently, the customer sent the sample out for testing.The customer did not provide the results from the alternate laboratory.Additionally, the customer reported there was delay in testing of about two days for total human chorionic gonadotropin (total hcg) due to issues with quality control recoveries.Furthermore, the customer indicated that they obtained discordant enhanced estradiol (ee2) results but declined to provide any further information.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: ADVIA CENTAUR CP
• Common Device Name: ADVIA CENTAUR CP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; neuwiesenstrasse 4; registration #: 3008494306; beringen 8222 ; SZ 8222
• Manufacturer Contact: douglas stanton ; 511 benedict avenue; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 19099272
• Report Number: 2432235-2024-00065
• Device Sequence Number: 12664342
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/12/2024

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 CP
• Device Catalogue Number: 10309710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/12/2024
• 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