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

Model Number	ADVIA CENTAUR CP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated intact parathyroid hormone (pth) result was obtained on a sample on an advia centaur cp instrument for a patient undergoing parathyroid surgery.The falsely elevated result was reported to the physician, who questioned the result.The sample was repeated multiple times and the repeat results recovered lower than the initial result.The result of 51.8 pg/ml was reported to the physician, as the correct result.There are no known reports of patient intervention or adverse health consequences due to the erroneous pth result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) to report that a falsely elevated intact parathyroid hormone (pth) result was obtained on a patient sample on an advia centaur cp instrument.The quality controls were acceptable at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During these visits, the cse inspected instrument and determined that the dispense of the reagent probe, sample probe and air pump, and wash and waste pump and tubing were acceptable.The cse also ran precision studies and found air bubbles in the wash 1 line coming from the bottle.The cse replaced and primed the bottle, and no more air bubbles were observed in the wash 1 lines.The cse ran a precision run, quality controls (qc), and samples in replicates, which recovered acceptably.Next, the customer ran a random sample in duplicate and the results differed.The cse subsequently replaced the tubing and wash stations and performed a precision run on the same sample, which recovered acceptably.Additionally, the cse cleaned the ionizer, replaced the valve manifold, aligned the reagent probe, and replaced the waste pump tubing.Then, the cse primed the instrument and performed precision studies, which recovered acceptably.The cause of the erroneous pth result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

• 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 ave.; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 16955725
• Report Number: 2432235-2023-00098
• Device Sequence Number: 11629494
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (Y/N): N
• 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): 05/18/2023

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: 04/21/2023
• Initial Report FDA Received Date: 05/18/2023
• 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