MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR TOTAL HCG; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	N/A
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The united states customer reported an observation of an elevated advia centaur cp total hcg (thcg), lot 357 result that was discordant relative to retest results.Quality control (qc) results and calibrations were within expected ranges at the time of patient testing.Siemens service was dispatched, and total service was performed on the instrument.Parts were replaced and qc and precision were evaluated and met acceptance criteria.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.
Event or Problem Description
The customer obtained an elevated advia centaur cp total hcg (thcg), lot 357 result that was discordant relative to retest results.The initial result was reported and questioned by the physician.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2024-00414 initial report on 17-sep-2024.Siemens investigated the united states customer report of an elevated advia centaur cp total hcg (thcg), lot 357, result that was discordant relative to retest result.The customer obtained a discordant patient result with advia centaur cp total hcg (thcg), lot 357.The initial patient result was reported and questioned by the physician.The sample was retested on a different day and a lower result was obtained and issued to the physician in a corrected report.The customer began testing samples in duplicate to ensure no additional outliers were observed.Quality control (qc) results and calibrations were within expected ranges at the time of patient testing.Siemens customer service engineer (cse) was dispatched to inspect the instrument and total service was performed.Parts were replaced and qc and precision were evaluated and met acceptance criteria.It was found that the sample was tested after routine instrument preventative maintenance had been performed on august 19, 2024.The customer has monitored performance following the service call and has had no further concerns.The customer is operational, and the reported issue was resolved by routine troubleshooting/service actions.A product problem was not identified.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• Brand Name: ADVIA CENTAUR TOTAL HCG
• Common Device Name: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 20239470
• Report Number: 1219913-2024-00414
• Device Sequence Number: 15487513
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: (01)00630414505152(10)44482357(17)241209
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 12/10/2024

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 Expiration Date: 12/09/2024
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 44482357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 12/10/2024
• Date Device Manufactured: 02/09/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female