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

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	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) and reported an observation of a discordant elevated advia centaur cp total hcg (thcg) result on a patient sample versus repeat testing.Siemens is evaluating this issue.
Event or Problem Description
The customer reports an observation of a discordant elevated advia centaur cp total hcg (thcg) result on a patient sample versus repeat testing.The initial erroneous result was not reported to the physician(s).The same sample was retested on the original advia centaur cp instrument four times and lower results were obtained.Two repeats resulted as erroneous and the lower results with value <2.0 miu/ml were reported as the correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr 1219913-2024-00300 was initially filed on 01-may-2024.Additional information became available after the initial filing, and siemens has concluded the problem investigation.Service inspection revealed an issue with a fluid leak affecting cuvettes at the wash station.Multiple fluidics components (pumps, tubing, manifold) were replaced as part of a routine service response, and the leak was resolved.Following the service intervention, thcg performance has been acceptable, and no further issues were reported.The instrument is performing according to specifications.No further evaluation of the device is required.In section h6, the codes for investigation findings, and investigation conclusions were updated.

• Brand Name: ADVIA CENTAUR TOTAL HCG (THCG)
• 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: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19220832
• Report Number: 1219913-2024-00300
• Device Sequence Number: 12502866
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/20/2024

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: 357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 35 YR
• Patient Sex: Female