MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT TOTAL HCG (THCG); HUMAN CHORIONIC GONADOTROPIN IMMUNOASSAY

Model Number	10308984
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer informed siemens that they have observed discordant advia centaur xpt total hcg (thcg) results, where the initial sample result is high and retest result is low (< 2).The complaint information indicates that the initial results are reported to physician(s), who question the results based on patient clinical history, and samples are retested.There are no allegations of patient intervention or adverse health consequences due to the elevated results.
Additional Manufacturer Narrative
An outside the united states (ous) customer contacted the siemens customer care center (ccc) reporting the observation of elevated initial patient results compared to lower retest results.The system was checked by the technical service technician and the sample was checked for preanalytical processes; no problems were detected.The interpretation of results section of the instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2022-00463 initial report on 2022-12-27.Additional information - 2023-02-28: siemens concluded the investigation for an outside of the united states (ous) customer allegation of elevated advia centaur xpt total hcg (thcg) initial patient results compared to lower retest results.Information was provided for one patient sample that initially resulted 238.0 miu/ml on an advia centaur xpt instrument (serial number (b)(6)).The same sample was retested on another advia centaur xpt at the laboratory and the result was < 0.0 miu/ml.The lower repeat result was reported to be the correct result.The complaint indicated that the advia centaur xpt instrument was checked by third party service and no issues were identified regarding the customer's pre-analytical process, such as draw site, collection tube type and centrifugation time/speed.The majority of patient samples tested by this customer are not affected.There are many possible causes for discordant results.While there is insufficient information to determine the cause of the issue reported by this customer, siemens cannot rule out pre-analytical variables or sample specific issues as contributing factors.Pre-analytical variables can affect the quality of the sample, and deviation from recommended best practices can impact results.Based on the investigation, a product problem has not been identified.Customer is operational.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ADVIA CENTAUR XPT TOTAL HCG (THCG)
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN IMMUNOASSAY
• 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: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 16052348
• Report Number: 1219913-2022-00463
• Device Sequence Number: 6394799
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 03/23/2023

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: 10308984
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 03/23/2023
• 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 Sex: Unknown