MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 TOXOPLASMA QUANTITATIVE 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	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a discordant falsely reactive patient result of 10.2 iu/ml when using immulite 2000 xpi toxoplasma quantitative igg (txp) when using kit lot 517.The customer expected a non reactive result.The sample was repeated with non-specific antibody blocking tube (nabt) and the result was 11.3 iu/ml which was still reactive, but with heterophilic blocking tubes (hbt) the result was 6.5 iu/ml which was indeterminate.The same sample was then run on an alternate method and the result was 0.7 iu/ml which was non reactive as expected.The initial results were reported to the physician(s) and were not questioned.A corrected report was issued.There are no known reports of adverse health consequences.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report discordant immulite 2000 xpi toxoplasma quantitative igg (txp) results when compared to an alternate method.The limitations section of the instructions for use states the following: "the results of the test must be taken within the context of the patient's clinical history, symptomology and other laboratory findings." siemens continues to investigate.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2022-00351 on 04-december-2022.Additional information on 21-feb-2023: siemens concluded the investigation for an outside of the united states (ous) customer observation of discordant immulite 2000 xpi toxoplasma quantitative igg (txp) results when using kit lot 517 in comparison to an alternate method.The sample was also tested for toxoplasma igm and that was non-reactive.Siemens reviewed customer's adjustment and was comparable with release.Qc recovery was within insert ranges.The customer treated the sample with heterophilic blocking tube (hbt) and/or non-specific antibody blocking tubes (nabt).The hbt result was equivocal while the nabt was still reactive.These results indicate heterophilic antibody interference could be causing the initially falsely reactive txp results of this patient sample.Per immulite 2000 xpi txp instructions for use (ifu) pil2ktxp-25, 2019-07-16) "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays.Samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result." siemens performed an investigation to determine if there had been a positive shift with immulite 2000 xpi txp kit lot 517.The investigation assessed internal data and customer data obtained from smart remote services (srs).Srs data was gathered and the percentage of samples resulting reactive, indeterminate, and non-reactive results for each kit lot was calculated.An increase in percent reactive results is not observed with immulite 2000 xpi txp kit lot 517.Based on internal panel data, interpretation variability for a single sample is observed historically.Review of the precision of the assay using immulite 2000 xpi txp kit lot 517 showed to be within specifications.Srs data and internal data do not confirm a positive shift in performance of immulite 2000 xpi txp kit lot 517.The investigation confirmed there has been no positive shift in performance for immulite 2000 xpi txp kit lot 517.Siemens cannot rule out pre-analytical factors such as sample handling or integrity, or sample specific effects as the cause of discordant results observed by the ous customer.The immulite 2000 xpi toxoplasma quantitative igg (txp) kit lot 517 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG
• Common Device Name: IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; gwynedd; llanberis ll55 4el, ; UK
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; registration #: 3002806944; gwynedd, llanberis ll55, 4el ; UK
• Manufacturer Contact: karen confort ; 511 benedict avenue; tarrytown, NY 10591 ; 3392069063
• MDR Report Key: 15920585
• Report Number: 2432235-2022-00351
• Device Sequence Number: 2454324
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 10381323
• Device Lot Number: 517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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