MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENATUR XPT TOXOPLASMA G (TOXO G); TOXOPLASMA GONDII IMMUNOASSAY

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	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics is investigating.Calibration and quality control (qc) data was acceptable.The customer used an sst collection tube.This sample is stored frozen (-20c) by the customer, who will provide it to siemens for internal investigation.The limitations section of the instructions for use states: "in geographic regions that have an apparent low prevalence of toxoplasma igg in asymptomatic populations, the positive predictive value of any assay is reduced due to the increased possibility that a positive result is actually falsely positive.As with all in vitro diagnostic assays, each laboratory should determine its own reference range(s) for the diagnostic evaluation of patient results.".
Event or Problem Description
A customer obtained a reactive (positive) patient result with the advia centaur xpt toxoplasma g (toxo g) assay.The reactive result was considered discordant when compared to the non-reactive (negative) results obtained when the sample was retested on two (2) alternate methods.The initial result was not reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant toxo g result.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2021-00367 initial report on 2021-07-02.Additional information - 2021-12-12 siemens performed an internal study with 100 patient samples.Fifty (50) normal patient samples were from siemens manufacturing and fifty (50) patient samples were retrieved from france.The samples were tested with advia centaur xp toxo g lots 269, 271 and 273 in replicates of 3 (n=3).Of the 100 samples tested, 95 samples recovered the same interpretations with all 3 lots and 5 patients recovered negative/equivocal.Siemens retrieved customer data from siemens remote services (srs) for advia centaur xp toxo g lots 269, 271 and 273.The three lots have similar interpretation recovery.Lot 269 lot 271 lot 273 negative 82.9% 83.7% 82.6% equivocal 0.3% 0.9% 0.5% positive 16.8% 15.4% 15.9% siemens continues to investigate.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2021-00367 initial report on 2021-07-02 and mdr 1219913-2021-00367 supplemental 1 report on 2022-01-06.Correction - 2022-05-12.In section h10 of mdr 1219913-2021-00367 supplemental 1 report that was filed on 2022-01-06, the following statement was incorrect: "of the (b)(4) samples tested, (b)(4) samples recovered the same interpretations with all 3 lots and 5 patients recovered negative/equivocal." the statement should have stated, "(b)(4) samples recovered the same interpretations with all 3 lots and 5 patients recovered negative/equivocal and 1 patient recovered equivocal/positive." additional information - 2022-04-13.Siemens concluded the investigation for an outside of the united states (ous) customer 's observation of a false reactive result of a non-pregnant patient using advia centaur toxoplasma igg (toxo g) lot 271 vs.Alternate methods.Siemens reviewed the customer's calibration data which recovered acceptably and similar to release.Quality control (qc) was acceptable.Siemens performed internal testing, where (b)(4) patient samples were run in replicates of 3 with advia centaur toxo g lots 269, 271 and 273.(b)(4) samples recovered the same interpretations with all 3 lots and 5 patients recovered negative/equivocal and 1 patient recovered equivocal/positive among the lots.The equivocal/positive sample was a cut off sample.Siemens performed internal troubleshooting testing with multiple samples returned by this customer.Depending on available sample volume, testing included human anti-mouse igg antibodies (hama), anti-nuclear antibodies (ana) and anti-mitochondrial antibodies (ama) and testing without the p30 antigen in the lite reagent.A customer sample with enough volume was obtained and was purified and sequenced.The most abundant protein in the patient sample was apob-100.Apob-100 is regularly present in general human population, for this to be the interferent, discordance would be present at a much higher rate.This suggests that the interferent is "apob-like", not apob-100 specifically.Siemens retrieved patient field data and lot 271 recovered similarly with other lots.No other similar complaints have been received for advia centaur toxo g lot 271.Based on the available information advia centaur toxoplasma igg (toxo g) lot 271 is performing as intended and a product performance issue has not been identified.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ADVIA CENATUR XPT TOXOPLASMA G (TOXO G)
• Common Device Name: TOXOPLASMA GONDII IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 12112393
• Report Number: 1219913-2021-00367
• Device Sequence Number: 11712373
• Product Code: LGD
• UDI-Device Identifier: 00630414208459
• UDI-Public: 00630414208459
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K102681
• 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): 05/12/2022

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: 01/12/2022
• Device Model Number: N/A
• Device Catalogue Number: 10310321
• Device Lot Number: 271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 12/12/2021; 04/13/2022
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 01/06/2022; 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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