MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT TOTAL HCG; TOTAL HCG IMMUNOASSAY

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	03/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer observed falsely elevated patient results on the advia centaur xpt total hcg (thcg) assay with reagent lot 335.On (b)(6) 2022, four fertility patients being evaluated prior to the start of fertility treatments resulted higher than the physician expected.The same samples were repeated on another advia centaur xpt in the laboratory (same reagent lot) and they resulted lower at 0.2 miu/ml which was clinically expected.Thcg level 1 control recovered near the upper limit of the customers range prior to generating the discordant results.Service was sent to check the system and they replaced connectors, recalibrated and verified thcg precision.Replacement of connectors is considered normal troubleshooting or maintenance for an issue of this nature.Following service, the level 1 control is running near target and the customer has had no further concerns with thcg performance.A potential product performance issue has not been identified.Customer is operational.No further action is required.The instructions for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the ifu states: "test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal nonpregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results- sometimes in consultation with other medical experts.".
Event or Problem Description
The customer observed advia centaur xpt total hcg (thcg) elevated results from four samples that were considered discordant compared to results generated on the same samples with an alternative advia centaur xpt.The initial results were reported and questioned by the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, elevated advia centaur xpt total hcg (thcg) results.

• Brand Name: ADVIA CENTAUR XPT TOTAL HCG
• Common Device Name: TOTAL HCG 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: barry memishian ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13971703
• Report Number: 1219913-2022-00098
• Device Sequence Number: 4477275
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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: 06/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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