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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted siemens customer care center to report a falsely depressed advia centaur cp total hcg result for one patient that was considered discordant with the repeat testing.The quality control (qc) was in range at the time of the event.The customer service engineer (cse) was sent to the customer site for system inspection and no issues were identified.Siemens investigated.The customer reports that the total hcg assay is performing within specifications, and they have no further concerns.This issue appears to have been isolated to just one patient sample.Siemens cannot definitively determine the cause of this discrepant result.Contributing factors such as preanalytical variables and/or sample handling cannot be completely ruled out.A potential product performance issue has not been identified.Advia centaur cp total hcg reagent lot 341 is performing as expected the ifu states in the limitations section: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present).Test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal non-pregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results - sometimes in consultation with other medical experts." no further evaluation of the device is required.
Event or Problem Description
The customer obtained a falsely depressed advia centaur cp total hcg result for one patient.The result was reported to the physician and questioned.The same patient sample was repeated and the result was higher.A corrected report was issued.There are no known reports of adverse health consequences due to the discordant depressed total hcg patient result.

• Brand Name: ADVIA CENTAUR CP TOTAL HCG
• Common Device Name: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avemue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 7372808688
• MDR Report Key: 15731330
• Report Number: 1219913-2022-00374
• Device Sequence Number: 17954855
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K925277
• 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): 11/03/2022

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: 04/08/2023
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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