MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOXOPLASMA IGG (TOXO G); ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center to report an observation of a positive (reactive) atellica im toxoplasma igg (toxo g) patient sample result that was considered discordant compared to the historically negative (non-reactive) results obtained for this patient when tested with alternate methods.Quality control (qc) were within range when the sample have been processed.The limitations section of the instructions for use (ifu) states: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis." the interpretation of results section of the 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.
Event or Problem Description
The customer obtained a positive (reactive) atellica im toxoplasma igg (toxo g) patient sample result that was considered discordant compared to the historically negative (non-reactive) results obtained for this patient when tested with alternate methods.The discordant result was not reported to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant toxo g result.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2023-00297 initial report on (b)(6) 2023.Siemens completed the investigation for a customer observation of a positive (reactive) atellica im toxoplasma igg (toxo g) patient sample result with lot 288 that was discordant compared to the historically negative (non-reactive) results obtained for this patient and compared to results from alternate test methods.According to the customer and siemens regional service center (rsc), this was a known negative patient for toxo g, therefore it was tested on multiple alternate methods.All results from the alternate methods (4 methods) were non-reactive (negative).Calibration and quality control (qc) data was not provided for siemens's review.Siemens requested sample volume availability and whether heterophilic blocking tube (hbt) and/or non-specific antibody blocking tube (nabt) testing has been performed.No information has been provided.Siemens (biostats function) evaluated patient field data and the complaint lot (lot 288) recovery of interpretation ranges are similar to other reagent lots.The customer could not provide the total number of negative results with lot 288 and specificity on the site cannot be calculated.However, the negative percent agreement of (b)(4) studies described in the atellica im toxo g assay instructions for use is (b)(4).Based on the results of the available information, a potential product issue has not been identified.The customer is operational.

• Brand Name: ATELLICA IM TOXOPLASMA IGG (TOXO G)
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registrations # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18190820
• Report Number: 1219913-2023-00297
• Device Sequence Number: 6466599
• Product Code: LGD
• UDI-Device Identifier: 00630414600123
• UDI-Public: 00630414600123
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K012183
• 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): 04/16/2024

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: 05/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995699
• Device Lot Number: 288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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