MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR TOTAL HCG; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated total hcg result was obtained on a patient sample on an advia centaur xpt system.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on the initial advia centaur xpt system.The repeat result was lower than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated total hcg result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report a falsely elevated total hcg result was obtained on a patient sample on an advia centaur xpt system.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on the initial advia centaur xpt system.The repeat result was lower than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).The sample was run in the primary tube.The sample was recentrifuged prior to repeating.Siemens investigation included an assessment of reagent, instrument, and sample data.Reagent issues were ruled out based on the quality control (qc) recovering within acceptable ranges.The customer declined service to the system and has no concerns with the system or the assay.Based on the available information, the cause of the discordant result is consistent with preanalytical variables.Return of the patient sample for further investigation is not warranted since the discordant result was not reproducible.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." no further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR TOTAL HCG
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney st.; east walpole, MA 02032 ; 7372808688
• MDR Report Key: 17998815
• Report Number: 1219913-2023-00268
• Device Sequence Number: 6680648
• Product Code: DHA
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K200210
• 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): 10/24/2023

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 Expiration Date: 01/14/2024
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/24/2023
• Date Device Manufactured: 03/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female