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

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 310811872
• Report Number: 1219913-2023-00044
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female