MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG; IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (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	07/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a discordant, reactive result on a patient sample using the immulite 2000 xpi toxoplasma quantitative igg (txp) assay.Service was provided by a third-party and a preventative maintenance was performed.Siemens healthcare diagnostics is investigating the cause of the event.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.".
Event or Problem Description
The customer observed a discordant, reactive initial result on a patient sample using the immulite 2000 xpi toxoplasma quantitative igg (txp) assay.The sample was repeated in duplicate, resulting reactive using the same reagent lot and instrument.The reactive results were not reported to the physician(s).The patient had previously tested nonreactive on the immulite 2000 xpi toxoplasma quantitative igg (txp) assay the prior month.The customer sent the patient samples to a reference laboratory for further testing on alternate toxoplasma igg and toxoplasma igm test methods, all resulting nonreactive.The reference laboratory toxoplasma igg nonreactive results were considered correct.There are no known reports that treatment was altered or prescribed or adverse health consequences due to the discordant toxoplasma quantitative igg (txp) results.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00411 initial report on 06-aug-2021 for discordant, reactive results on a patient sample.On 12-aug-2021: additional information: siemens has been informed that the system water test (pm) was checked and was acceptable.Heterophilic blocking tube (hbt) and non-specific antibody blocking tube (nabt) testing were not performed on the patient sample by the customer.The total number of results generated by the customer with reagent lot 516 is 149 results <5 iu/ml (nonreactive (negative), 15 tests between 5 iu/ml to 8 iu/ml, and 24 tests greater than 8 iu/ml.Siemens continues to investigate and has inquired if the patient sample is available for further testing.Correction: siemens has been informed that the date of testing for the results 11.3 iu/ml and 10.6 iu/ml stated in section b6 occurred on (b)(6) 2021 and not on (b)(6) 2021 as initially provided by the customer.Section b3 (date of event) was updated to reflect the date of (b)(6) 2021.
Additional Manufacturer Narrative
Siemens filed mdr initial report on 06-aug-2021 for discordant, reactive results on a patient sample.Mdr supplemental report 1 was filed on 02-sep-2021 for a correction and additional information.15-oct-2021 additional information: siemens has completed the investigation.A customer from outside the united states reported false reactive results on a patient for toxoplasma quantitative igg (txp) when tested on the immulite 2000 xpi with reagent lot 516.Historically the patient had nonreactive txp results when previously tested on the system with txp reagent lot 516 and consistently nonreactive toxoplasma igm capture (txm) results.The customer repeated the sample, and it was reactive.The patient sample when tested on an alternate method was nonreactive.Siemens reviewed the customer's adjustment and quality control (qc) data produced with txp reagent lot 502 and the results were comparable to release with reagent lot 516.A third-party engineer performed a preventative maintenance (pm) post this event, the system water test was checked and acceptable (actual results not provided).The customer did not test the sample with heterophilic blocking tube (hbt) and /or with non-specific antibody blocking tubes (nabt) and did not provide information if sample is available for further internal testing.The calculated specificity for this customer for txp reagent lot 516 is calculated to 149/150= 0.993 x 100= 99.3 %.The specificity results from the 3 studies in the immulite 1000 toxoplasma quantitative igg ifu (comparable to the immulite 2000 toxoplasma quantitative igg specificity) have 95% confidence limits ranging from 94.2% - 100%.While there is insufficient information to determine the potential cause of the false reactive txp results, siemens cannot rule out possible heterophilic antibodies.The customer has not reported any new similar cases, and this seems to be an isolated event and/or sample specific issue.A search of the complaint database (gsms) on 15-oct-2021 found no other complaints with immulite 2000 xpi toxoplasma quantitative igg (txp) reagent lot 516.Based on the available information, the immulite 2000 xpi toxoplasma quantitative igg reagent lot 516 is performing as intended and a product performance issue has not been identified.The customer is operational.The assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation findings code and the investigation conclusion code were revised.

• Brand Name: IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG
• Common Device Name: IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (TXP)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd; ll55 4el, ; UK
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PROCUDTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 12291527
• Report Number: 1219913-2021-00411
• Device Sequence Number: 20050710
• 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): 11/08/2021

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: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381323
• Device Lot Number: 516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 10/15/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/02/2021; 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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 Sex: Female