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	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a reactive (positive) atellica im toxo g result for one patient which was discordant relative to repeat testing.Quality control (qc) results were within expected ranges both before and after the discordant measurement.The assay's 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.
Event or Problem Description
The customer reports observation of a positive atellica im toxoplasma igg (toxo g) result which was discordant relative to repeat testing.An initial reactive (positive) result was obtained for the affected patient and reported to the physician.The physician questioned the result, and a new test was performed using a different atellica im analyzer.The re-test result was nonreactive (negative), and accepted as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a positive atellica im toxoplasma igg (toxo g) result which was discordant relative to repeat testing when using toxo g kit lot 287.Repeat testing was performed using a different atellica im analyzer and a different reagent lot (288); the result was nonreactive (negative).The nonreactive result was considered correct.Siemens reviewed the customer¿s quality control (qc) results for this assay, and no issues were identified.Review of instrument log data did not show any evidence of hardware issues affecting handling of reagents or sample.A siemens field engineer checked the affected system, and performed some minor repairs, adjustment, and cleaning.The negative qc sample demonstrated some intermittent high results following the initial intervention, but following an additional service check, the results were again acceptable.Siemens review of customer field data from june 2022 through october 2023 (1,327,199 data points) showed that the result interpretation rate for toxo g lot 287 is comparable to that of other lots.No systemic bias was demonstrated.The customer¿s effective toxo g specificity could not be estimated, as the necessary result data were not provided.The customer has not reported any new observations of false-reactive toxo g results following service, and the incident appears to be an isolated event.No product problem was identified.The customer is operational, and no further action is required.Note: in section h6, the codes for type of investigation, investigation findings, and investigation conclusions have been updated.

• 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.; east walpole MA
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 17989299
• Report Number: 1219913-2023-00267
• Device Sequence Number: 15289829
• Product Code: LGD
• UDI-Device Identifier: 00630414600123
• UDI-Public: 00630414600123
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/04/2024

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: 04/12/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995699
• Device Lot Number: 287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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