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	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer obtained a discordant reactive (positive) atellica im toxoplasma igg (toxo g) lot 295 result on a sample from a pregnant patient ( (b)(6) 2024).The positive result was reported to the physician and was questioned because the patient had been previously tested at a non-customer with an alternate test method and results were negative ( (b)(6) 2024).The following information was also provided: a negative toxo m result was obtained for this patient.An historical atellica im toxo g result (36 ui/ml from (b)(6) 2024) was provided for this patient.The customer sent all tubes to a reference lab and negative results were obtained.There are no allegations of patient harm, changes in treatment, or adverse health consequences due to the event.The interpretation of results section of the instructions for use (ifu) states: "the detection of toxoplasma igg in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity." "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 reactive (positive) atellica im toxoplasma igg (toxo g) lot 295 result on a sample from a pregnant patient.The positive result was reported to the physician and was questioned because the patient had been previously tested at a non-customer with an alternate test method and results were non-reactive (negative).The negative results are believed to be correct.There are no allegations of patient harm, changes in treatment, or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2024-00421 on 2024-09-23.Siemens completed investigation for an outside of the united states (ous) customer complaint of a reactive (positive) atellica im toxoplasma igg (toxo g) lot: 295 results for one patient.The patient was tested with alternate methods and the results were negative.Siemens reviewed customer's calibration and quality control (qc) data, which were valid and within range.Siemens reviewed toxo g lot: 295 qc and medical decision pool lot release data.Results met lot criteria and recovered similar with other lots.The customer¿s calibration and qc results were comparable to the lot release data.Siemens retrieved field patient data from 11/01/2023 till 11/13/2024 with total n= 627,647 for lots: 291, 292, 295 and 296.Lot: 295 recovery is similar to other lots.The customer received another sample draw and tested with non-specific antibody blocking tube (nabt) which also resulted as reactive.The customer has not had any similar issues, and this seems to be a patient specific issue.The calculated specificity of this customer for toxo g lot: 295 is 142/ 143 = 0.9949 x100= 99.49 %, which is similar to the relative specificity based on 3 studies as described in the atellica im ifu 10995430_en rev.03, 2022-05 of 99.3%.Based on the available information, the cause of the discordance is inconclusive but isolated.The customer is operational, and the reported issue is resolved by routine troubleshooting.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: 20280230
• Report Number: 1219913-2024-00421
• Device Sequence Number: 7563909
• Product Code: LGD
• UDI-Device Identifier: 00630414600123
• UDI-Public: (01)00630414600123(10)72181295(17)250307
• 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): 01/08/2025

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: 03/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995699
• Device Lot Number: 72181295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 01/08/2025
• Date Device Manufactured: 03/07/2024
• 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: 36 YR
• Patient Sex: Female