MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG; 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	04/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center to report a positive immulite 2000 xpi toxoplasma quantitative igg result for a patient sample that was considered discordant when compared to the negative results from the advia centaur system and an alternate method.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 a discordant positive result on the immulite 2000 xpi toxoplasma quantitative igg (txp) using lot 519 for a patient sample when compared to the negative results from the advia centaur system and an alternate method.The result was reported to the physician and questioned.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant positive immulite 2000 xpi toxoplasma quantitative igg (txp) result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2022-00146 on may 12, 2022.May 17, 2022 additional information: an outside of the united states (ous) customer contacted the siemens customer care center to report a positive immulite 2000 xpi toxoplasma quantitative igg result for a patient sample that was considered discordant when compared to the negative results from the advia centaur system and an alternate method.The quality control (qc) for level 2 was out of range on april 22, 2022.It is unknown why the qc was out of range.On april 27, 2022, the customer service engineer (cse) replaced the spring for the sample drd.On a later date, the second spring for the sample drd was replaced.The customer did not test the sample with hbt (heterophilic blocking tube) / nabt (non-specific antibody blocking tube).The customer stopped using the toxoplasma quantitative igg lot 519 and is using lot 517.For the advia centaur system, the customer used reagent lot 277 in april 2022 and is currently using lot 272.The customer does not have enough sample for further testing and investigation.Siemens continues to investigate.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2022-00146 on may 12, 2022.Siemens filed the mdr 1219913-2022-00146 supplemental report 1 on june 08, 2022.June 27, 2022 additional information: an outside of the united states (ous) customer contacted the siemens customer care center to report a positive immulite 2000 xpi toxoplasma quantitative igg result for a patient sample that was considered discordant when compared to the negative results from the advia centaur system and an alternate method.Siemens reviewed the customer's adjustment data and it was comparable to release.Quality control (qc) data was reviewed and it was noted that one of the levels was high on the date of the discordant results.A siemens field service engineer checked the system twice and made adjustments to the sample and reagent probe drd and sample syringe.There was not sufficient sample volume available to be sent to the manufacturer site for further evaluation.The sample was not tested with non-specific antibody blocking tubes (nabt) or heterophilic blocking tubes (hbt) at the customer site.Siemens retrieved field patient data from 05/13/2021 to 05/13/2022 and txp lot 519 was comparable with the previous lots.The customer tried txp kit lot 517 for troubleshooting purposes and still noted some false positive results versus the advia centaur system, but data was not provided per siemens requests for evaluation.The calculated specificity for the customer with the immulite 2000 xpi toxoplasma quantitative igg (txp) kit lot 519 based on the data provided is 102/104= 0.981 x100= 98.1%.The specificity results from the three (3) studies in the immulite 1000 toxoplasma quantitative igg ifu (which is where the immulite 2000 toxoplasma quantitative igg claim resides) have 95% confidence limits ranging from 94.2% - 100%.Based on the information available, the immulite 2000 xpi toxoplasma quantitative igg kit lot 519 is performing as intended and a product specific issue has not been identified.No further evaluation of the device is required.

• Brand Name: IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG
• 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: 14375866
• Report Number: 1219913-2022-00146
• Device Sequence Number: 14949918
• 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,Followup
• Report Date (Section B): 07/13/2022

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: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381323
• Device Lot Number: 519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 05/17/2022; 06/27/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/08/2022; 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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