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	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained repeat reactive (positive) atellica im toxoplasma igg (toxo g) results for a patient that were discordant relative to alternate method test result and the patient's clinical presentation and an historical result.The customer obtained an initial positive atellica im toxo g result on a sample (b)(6) from the patient on (b)(6) 2025.Retesting was performed and also resulted positive (n=2).A new sample (b)(6) was drawn from the same patient on the next day (b)(6) 2025, and the result was positive.The customer sent one of the samples to another lab for alternate method testing, which resulted non-reactive (negative).This result was accepted as correct as it was consistent with the patient's clinical presentation and historical result.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
The ous customer obtained repeat reactive (positive) atellica im toxoplasma igg (toxo g) results for a patient that were discordant relative to alternate method test result and the patient's clinical presentation and an historical result.The customer obtained an initial positive atellica im toxo g result on a sample (b)(6) from the patient on (b)(6) 2025.Retesting was performed and also resulted positive (n=2).A new sample (b)(6) was drawn from the same patient on the next day (b)(6) 2025, and the result was positive.The customer sent one of the samples to another lab for alternate method testing, which resulted non-reactive (negative).This result was accepted as correct as it was consistent with the patient's clinical presentation and historical result.There are no allegations of patient or user intervention or adverse health consequences due to the event.It was noted that the patient was negative for toxoplasma igm.The atellica im toxo g instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.Note: this report is for the discordant result obtained on (b)(6) 2025.A separate report is submitted for the discordant results obtained (b)(6) 2025.

• 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: 24225797
• Report Number: 1219913-2026-00029
• Device Sequence Number: 9265805
• Product Code: LGD
• UDI-Device Identifier: 00630414600123
• UDI-Public: (01)00630414600123(10)53871298(17)260616
• 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): 06/09/2026

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: 06/16/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995699
• Device Lot Number: 53871298
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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: 26 YR
• Patient Sex: Female