MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP); IMMUNOASSAY, TOXOPLASMA GONDII IGG

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	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center to report reactive (positive) immulite 2000 xpi toxoplasma quantitative igg results for a patient sample that were considered discordant when compared to the nonreactive (negative) previous result.The ifu states in the limitations section: "the results of the test must be taken within the context of the patient's clinical history, symptomology and other laboratory findings." siemens healthcare diagnostics is investigating.
Event or Problem Description
The customer obtained reactive (positive) results for the immulite 2000 xpi toxoplasma quantitative igg (txp) using lot 515 for a patient sample that was considered discordant when compared to the nonreactive (negative) previous result.The value for the results was greater than 250 iu/ml.The customer collected a new sample for testing and the result was nonreactive (negative).The initial sample from (b)(6) 2022 was thawed and retested.The results were nonreactive (negative).The initial result was reported to the physician and was not questioned.There are no known reports of patient intervention or adverse health consequences due to the discordant toxoplasma quantitative igg (txp) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2022-00154 on may 27, 2022.June 27, 2022 additional information: an outside of the united states (ous) customer contacted the siemens customer care center to report reactive (positive) immulite 2000 xpi toxoplasma quantitative igg results for a patient sample that were considered discordant when compared to the nonreactive (negative) previous result.Siemens investigated.The customer's adjustment data was valid and qc recovery was acceptable.However, the actual data was not provided for evaluation.Siemens requested the sample handling information and investigation files from the customer.The information was not provided despite multiple requests.The total number of negative results was not provided and the calculated specificity for the customer with the immulite 2000 xpi toxoplasma igg kit lot 515 cannot be calculated.Preanalytic factors and/or sample handling leading to particulate matter cannot be ruled out for the non-reproducible false reactive immulite 2000 xpi toxoplasma igg result.Siemens retrieved field patient data from may 13, 2021 to may 13, 2022 and lot 515 performance was comparable with the previous lots.Based on the information available immulite 2000 xpi toxoplasma quantitative igg kit lot 515 is performing as intended and a product specific issue has not been identified.No further evaluation of the device is required.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP)
• Common Device Name: IMMUNOASSAY, TOXOPLASMA GONDII IGG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 7372808688
• MDR Report Key: 14521666
• Report Number: 1219913-2022-00154
• Device Sequence Number: 12369341
• Product Code: LGD
• UDI-Device Identifier: 00630414962238
• UDI-Public: 00630414962238
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K962936
• 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): 07/20/2022

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: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381323
• Device Lot Number: 515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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: 27 YR
• Patient Sex: Female