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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an advia centaur xp instrument.The quality control (qc) and calibration were acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse replaced photo multiplier tube (pmt) of the luminometer.Furthermore, the cse performed the dark tests with and without cuvettes.The cse determined that the parameters of the dark tests were as expected.The cse performed the calibration, qc and a routine check for all tests, which passed.The cse returned to the customer¿s site and identified a leak in the wash manifold.The cse subsequently replaced the connector fitting and performed a visual protocol to verify acceptable wash performance.A precision study was also performed on qc, which recovered acceptably.The cause of the erroneous result is unknown.The instrument is performing according to the specification.No further evaluation is needed.
Event or Problem Description
A falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an advia centaur xp instrument.The erroneous result was reported to the physician(s), who questioned the result.Two days later, the sample was repeated on the initial advia centaur xp instrument.The repeat result was lower than the erroneous result.The patient was redrawn and the new sample was processed on the initial instrument, and the result correlated with the repeat result.The result from the new sample was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated thcg result.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co,; registration number: 8020888; dublin ; EI
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 17510092
• Report Number: 2432235-2023-00233
• Device Sequence Number: 15435747
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: 00630414573564
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2023

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 XP
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2013
• 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 Age: 19 YR
• Patient Sex: Female