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	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2025-00198 initial report on 25-oct-2025.Additional information - 05-nov-2025: the product lot number was not available at the time that mdr 1219913-2025-00198 initial report was filed but has since been provided to siemens.Sections d4 and h4 of this supplemental 1 report contain the lot information.Siemens continues to investigate.
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer obtained an initial reactive (positive) atellica im toxoplasma igg (toxo g) result on sample from a pregnant female patient.The sample was retested after centrifuging and the result was positive.The sample was tested on two different alternate methods, and the results were non-reactive (negative).The initial positive results were not reported; the negative results were reported as correct.There are no allegations of patient or user intervention or adverse health consequences due to the event.The assay's 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.
Event or Problem Description
The customer obtained an initial reactive (positive) atellica im toxoplasma igg (toxo g) result on sample from a pregnant female patient.The sample was retested after centrifuging and the result was positive.The sample was tested on two different alternate methods, and the results were non-reactive (negative).The initial positive results were not reported; the negative results were reported as correct.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens completed the investigation of repeat reactive (positive) atellica im toxoplasma igg (toxo g) results on a sample from a pregnant female patient that was non-reactive (negative) upon retesting with alternate methods.Siemens ruled out reagent issues based on a review of quality control (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.Siemens retrieved field peer patient data (b)(4) from (b)(6) 2024 to (b)(6) 2025 and toxo g lots 292, 295, 296, 297 and 298.Lot 297 qualitative recovery was similar with other lots.The customer did not test the sample with heterophilic blocking tubes (hbt) and there is no sample volume available for further testing.The total number of negative results with toxo g lot 297 could not be provided by the customer, therefore customer's specificity could not be calculated.Per the atellica im toxo g instructions for use (ifu), the total initial relative specificity from 3 studies was (b)(4).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." based on the available information, the probable cause of the discordant result cannot be determined but this appears to be a sample specific issue.The customer is operational after repeating the sample on an alternate method.Siemens filed mdr 1219913-2025-00198 on 25-oct-2025 and mdr 1219913-2025-00198 supplemental 1 on 18-nov-2025.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 23386580
• Report Number: 1219913-2025-00198
• Device Sequence Number: 14694111
• Product Code: LGD
• UDI-Device Identifier: 00630414600123
• UDI-Public: (01)00630414600123(10)88644297(17)260109
• 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,Followup
• Report Date (Section B): 02/25/2026

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: 01/09/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995699
• Device Lot Number: 88644297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/05/2025; Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/18/2025; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• 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 Age: 25 YR
• Patient Sex: Female