MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT TOTAL HCG (THCG) ASSAY

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	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states customer obtained a discordant elevated advia centaur xpt - total hcg (thcg) result for a pregnant female patient.The initial result was reported to the physician, who questioned the results.The sample was remeasured twice on same advia centaur xpt, and the results were lower.This sample was also diluted onboard with the dilutions of 1:10, 1:100 and 1:200 and all the diluted results resulted as errors.Quality control was in range at the time of testing and no instrument errors were found with the system during this event.The interpretation of results section of the advia centaur xpt total hcg instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens continues to investigate.
Event or Problem Description
The customer obtained a discordant elevated advia centaur xpt - total hcg (thcg) result for a pregnant female patient.The initial result was reported to the physician, who questioned the results.The sample was remeasured twice on same advia centaur xpt, and the results were lower.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xpt total hcg result.
Additional Manufacturer Narrative
Initial mdr 1219913-2023-00044 was filed on (b)(6) 2023 reporting a customer from outside the united states obtained a discordant elevated advia centaur xpt - total hcg (thcg) result for a pregnant female patient.The initial result was reported to the physician, who questioned the results.The sample was remeasured twice on same advia centaur xpt, and the results were lower.This sample was also diluted onboard with the dilutions of 1:10, 1:100 and 1:200 and all the diluted results resulted as errors.Additional information - (b)(6) 2023.The customer observed a falsely elevated, non-reproducible total human chorionic gonadotropin (thcg) patient sample using reagent lot 341 on an advia centaur xpt.On (b)(6) 2023, an initial thcg result of 670.2 miu/ml was reported to the physician and questioned.The sample was re-centrifuged and repeated, which produced results of 45.4 miu/ml and 56.5 miu/ml, the former of which was reported to and accepted by the physician.Biorad controls were within expected ranges, and no instrument errors were reported during the day of this event.There were no issues with other samples tested on the day of this event.The instrument was serviced on (b)(6) 2023 in which reagent probes were recalibrated, and the reagent mixer and acid/base pumps were checked.These service actions are considered normal troubleshooting for an issue of this nature.Thcg precision was verified following service and was acceptable.Based on available information, the cause of the discordant result is consistent with sample integrity and/or a sample handling issue.No potential product issue is observed.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR XPT TOTAL HCG (THCG) ASSAY
• Common Device Name: TOTAL HCG (THCG) ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16486178
• Report Number: 1219913-2023-00044
• Device Sequence Number: 20248862
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K925277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: 04/08/2023
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• 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: 02/26/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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: 29 YR
• Patient Sex: Female