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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating.There were no other issues observed with other samples.The ifu states in the interpretation of results section: "interpretation of results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present).".

Event Description

A discordant, initially high total hcg (thcg) patient sample result was obtained on an advia centaur xpt instrument.The discordant result was reported to the physician and questioned.The sample was repeated on the original advia centaur xpt and a 2nd advia centaur xpt on site.The repeat results were lower than the discordant result.The repeat result was reported, as the corrected result, to the physician.There are no known reports of patient intervention, or adverse health consequences due to the discordant, thcg result.

Manufacturer Narrative

Mdr was filed on december 21, 2020.Additional informatin january 7, 2021: the cse arrived on site and performed a total service call to investigate quality control and precision issues.The cse performed several checks and troubleshooting steps including adjusting cuvette bottom calibration for sample probe, cleaning the mechanism along the syringe and reagent probes, replacing reagent probe 1, and adjusting reagent probe 1 calibration the cse then ran quality control for all assays which passed successfully, with a slight improvement on hcg.Results as follows : rlu conc 6446 6.8; 5716 5.3; 5576 5.0; 5585 5.0; 5619 5.1; 5683 5.2; 5559 5.0; 5655 5.2; 5576 5.0; 5786 5.4; 5859 5.6; 5898 5.7; 6081 6.1; 5669 5.2; 5689 5.2; 6007 5.9; 5853 5.6; 5781 5.4; 6046 6.0; 5667 5.2.The customer calibrated hcg and the following quality control run was successful.The system is now operational and fully functional.The customer ran all samples in duplicate.Siemens continued to monitor performance of the assay at the customer's site.No additional, elevated results have been observed.Additional information - february 1, 2021 siemens reviewed the instrument and event data including actions performed by the customer service engineer (cse).Siemens concluded that the probable cause of the discordant result was due to the misalignment of the reagent probe 1 utilized by the total hcg assay.The issue was resolved with the replacement of the probe and recalibration of the alignment as part of normal routine instrument troubleshooting.Based on the investigation, no product problem was identified.The system is operating as expected.The advia centaur thcg assay, lot 322 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR TOTAL HCG (THCG)
• Type of Device: RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11051719
• MDR Text Key: 223454377
• Report Number: 1219913-2020-00663
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (y/n): N
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Patient Sequence Number: 1