MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG; ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report a falsely elevated toxoplasma quantitative igg result that was obtained on a patient sample on an immulite 2000 xpi instrument.Quality controls (qcs) recovered within ranges on the day of the event.Per the limitations section of the immulite 2000 toxoplasma quantitative igg instructions for use (ifu): "the results of the test must be taken within the context of the patient's clinical history, symptomology and other laboratory findings." siemens evaluated this issue and provided the following conclusion: the system water test was reviewed and found within specification.The customer tested the repeatability on other assays, and results for other assays were within siemens specifications.Siemens asked for maindata, errorlogs and spy files for evaluation.No data was available.Additionally, operator could not provide more detail information about the patient.Customer stated that the reported issue was an isolated event.Based on the available information, the cause of the discordant result is consistent with a sample integrity issue.The customer is operational, and the reported issue is resolved by routine troubleshooting.
Event or Problem Description
A falsely elevated (reactive) toxoplasma quantitative igg result was obtained on a patient sample on an immulite 2000 xpi instrument.The erroneous result was not reported to the physician(s).For troubleshooting, the sample was repeated in multiple replicates on the same instrument on two additional dates.The repeat results were lower than the erroneous result.Most repeat results were nonreactive, one repeat result was indeterminate, and two repeat results were reactive.The sample was also tested with the toxoplasma igm assay on the immulite 2000 xpi instrument and was nonreactive for toxoplasma igm.Historical results from (b)(6) 2023 were nonreactive for toxoplasma igg and toxoplasma igm.Alternate laboratory results from february 2024 (instrument unknown) were nonreactive for toxoplasma igg and toxoplasma igm.The nonreactive toxoplasma igg result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated toxoplasma quantitative igg result.

• Brand Name: IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; llanberis LL554 EL; UK LL554EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy, gwynedd; uk registration #: 3002806944; llanberis, gwynedd LL554 EL; UK LL554EL
• Manufacturer Contact: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 18924591
• Report Number: 1219913-2024-00171
• Device Sequence Number: 11881927
• Product Code: LGD
• UDI-Device Identifier: 00630414962238
• UDI-Public: 00630414962238
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/18/2024

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 10381323
• Device Lot Number: 523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/18/2024
• Date Device Manufactured: 10/12/2023
• 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