MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED ADVIA CENTAUR ANTI-THYROGLOBULIN II (ATGII); ANTI-THYROGLOBULIN IMMUNOASSAY

Catalog Number 11201760

Device Problem High Test Results (2457)

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

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted siemens to report a discordant (depressed) patient result with advia centaur anti-thyroglobulin ii (atgii) lot 024.Bio-rad liquichek specialty lot 64940 qc results are lower, but are within insert ranges.Siemens reviewed the system remote services (srs) database for field patient data on advia centaur atgii reagent lots 018 and 024.Data shows the percentage of patient samples above and below the assay cutoff of 4.5 iu/ml is within 5% between the two reagent lots.The interpretation of results section of the instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating the issue.

Event Description

The customer observed a bias in patient results and quality control (qc) using the advia centaur anti-thyroglobulin ii (atgii) assay, where new lot 024 is lower than previous lot 018.Bio-rad liquichek specialty lot 64940 qc results are lower, but are within insert ranges.Resultsfor both lots were reported to physician and were questioned.There are no known reports of patient intervention or adverse health consequences due to the atgii bias.

Manufacturer Narrative

The initial mdr 1219913-2023-00054 was filed on march 16, 2023.Additional information - march 23, 2023: siemens completed investigation for an outside of the united states (ous) customer observation of a low shift in both control and patient results using the advia centaur anti-thyroglobulin ii (atgii) assay when comparing reagent lot 024 to reagent lot 018.Biorad liquichek specialty quality control (qc) lot 64940 results are within package insert ranges.The patient samples were run on different days using the two different reagent lots.Siemens reviewed system remote services (srs) patient data for advia centaur atgii reagent lots 018 and 024.The data showed the percentage of patient samples above and below the assay cutoff of 4.5 iu/ml is within 5% between the two reagent lots.This is within normal lot to lot variability.Based on the results of the investigation, a potential product issue has not been identified.The customer is operational.

• Brand Name: ADVIA CENTAUR ANTI-THYROGLOBULIN II (ATGII)
• Type of Device: ANTI-THYROGLOBULIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis LL55 4EL; UK LL55 4EL
• 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: 16560963
• MDR Text Key: 311601417
• Report Number: 1219913-2023-00054
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Catalogue Number: 11201760
• Device Lot Number: 024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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