MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG; IMMULITE 2000 TXP

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	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer observed reactive immulite 2000 toxoplasma quantitative igg (txp) results for one patient which were discordant compared to patient history and alternate-method testing.Siemens is reviewing adjustments and quality control results.Siemens continues to investigate.The limitations section of the instructions for use states: "the results of this test must be taken within the context of the patient's clinical history, symptomology and other laboratory findings." mdrs 1219913-2021-00098 and 1219913-2021-00099 were filed for a different sample from the same patient tested on a different day.
Event or Problem Description
When using the immulite 2000 toxoplasma quantitative igg (txp) assay, the customer observed reactive (positive) results for one patient which were discordant relative to alternate-method testing.There are no known reports of patient intervention or adverse health consequences due to the discordant results.
Additional Manufacturer Narrative
Mdr 1219913-2021-00100 was submitted on 11-feb-2021 to report an observation of a reactive (positive) immulite 2000 toxoplasma quantitative igg (txp) result which was discordant relative to patient history and alternate-method testing.Siemens healthcare diagnostics has concluded the incident investigation.Siemens reviewed the customer's calibration and quality control data, and did not identify any issues.An estimate of this customer's observed txp-assay specificity (99.1%) is consistent with expected performance.There was insufficient patient sample to permit additional investigation and the affected patient did not return for follow-up testing.The observed discordance appears to be an isolated, patient-specific issue, and siemens cannot rule out pre-analytical factors or sample-related issues.Based on the investigation, no product problem was identified, and it was determined that the immulite 2000 toxoplasma quantitative igg (txp) assay is performing as intended.No further action is required.Coding for investigation findings and investigation conclusions has been updated in section h6.Note: mdrs 1219913-2021-00098 supplemental 1 and 1219913-2021-00099 supplemental 1 have filed in association with other test observations for the same patient.

• Brand Name: IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG
• Common Device Name: IMMULITE 2000 TXP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 11317810
• Report Number: 1219913-2021-00100
• Device Sequence Number: 11596953
• Product Code: LGD
• UDI-Device Identifier: 00630414962238
• UDI-Public: 00630414962238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 10381323
• Device Lot Number: 507
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1