MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOXOPLASMA IGG (TOXO G); TOXOPLASMA GONDII IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

The quality control was acceptable at the time the patient results were generated.Siemens healthcare diagnostics is investigating the cause for the discordant toxo g results.The ifu states in the limitations section: "specimens collected in the early stages of infection may have igg levels that are classified as negative.In geographic regions that have an apparent low prevalence of toxoplasma igg in asymptomatic populations, the positive predictive value of any assay is reduced due to the increased possibility that a positive result is actually falsely positive.As with all in vitro diagnostic assays, each laboratory should determine its own reference range(s) for the diagnostic evaluation of patient results." mdr 1219913-2020-00026 (december 31, 2019) , and mdr 1219913-2020-00027 (january 4, 2020) were filed for the same event.

Event Description

False positive atellica im toxoplasma igg (toxo g) results were obtained on samples from the same patient.The previous results for the patient were negative.The patient sample was tested on alternate methods and the results were negative.A corrected report was issued.The toxoplasma igm (toxo m) results were negative.The patient is pregnant.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant toxoplasma g results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00025 on (b)(6) 2020.Siemens filed the mdr 1219913-2020-00025 supplemental report 1 on (b)(6) 2020.(b)(6) 2020 additional information: siemens tested the patient sample that was sent by the customer to the manufacturing site.The atellica im (aim) toxo g lots 252 and 258 were used for the testing.All lots were calibrated/adjusted and siemens toxo g controls were used for verification.Recovery of quality control replicates (n=3) for all levels were within ifu limits.The customer returned sample was tested (n=2) on the atellica im.Toxo g results (iu/ml): customer sample neat: platform ; lot ; replicate 1 ; replicate 2 ; mean; atellica im ; 252 ; 290.6 ; 293.0 ; 291.8; atellica im ; 258 ; >700 ; >700 ; >700; customer sample hbt: platform ; lot ; replicate 1 ; replicate 2; mean; atellica im ; 252 ; 322.1 ; 288.7 ; 305.4; atellica im; 258 ; >700 ; >700 ; >700; customer sample nabt: platform ; lot ; replicate 1 ; replicate 2 ; mean; atellica im ; 252 ; 301.0 ; qns ; 301.0; atellica im ; 258 ; >700 ; qns ; >700; qns=quantity not sufficient.The sample was reactive (positive) on the atellica im with all lots.The siemens' study replicated the customer's observations of the false reactive results for this patient with the atellica im.The reactive results were produced with multiple toxo g reagent lots indicating this is not a lot specific issue.The customer returned sample was tested with hbt (heterophilic blocking tube) and nabt (non-specific antibody blocking tube) on all the atellica im toxo g lots.Results post hbt and nabt were still reactive on the atellica im systems and with all toxo g lots.The customer's data along with the siemens' data of the false positive toxo g results indicate that this is not an atellica im toxo g specific lot and/or system specific issue, but rather a sample specific issue and unknown interferents like anti-nuclear antibodies (ana) and anti-mitochondrial antibodies (ama) cannot be ruled out.The atellica im toxo g ifu states in the limitations section: "the presence of anti-nuclear antibodies (ana) and anti-mitochondrial antibodies (ama) in samples from patients with autoimmune syndrome may interfere with the atellica im toxo g assay and give falsely positive or falsely negative results.These samples should not be tested." siemens retrieved 13 month sas (siemens analytics services) patient data.The data included 338,073 results from 07 march 2019 to 23 april 2020 and toxo g lots 235, 239, 243, 245, 247, 249, 251, 258 and 258.The following lots have been summarized on the rate of interpretations: lots ; 247 ; 249 ; 251 ; 252 ; 258; non-reactive ; 7790 (85.94%) 8558 (79.35%) ; 41866 (82.95%) ; 115616 (85.15%) ; 28892; (86.09%);; equivocal ; 116 (1.28%) ; 101 (0.94%) ; 708 (1.4%) ; 1480 (10.9%) ; 290 (0.86%); reactive ; 1158 (12.78%) ; 2126 (19.7%) ; 7897 (15.65%) ; 18591 (13.69%) 4380 (13.05%); total ; 9064 ; 10785 50471 ; 135778 ; 33562;; lot 258 recovery is comparable with the other lots.Siemens is awaiting the information requested in order to further evaluate the issue.Mdr 1219913-2020-00026 supplemental report 2 and mdr 1219913-2020-00027 supplemental report 2 were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00025 on january 31, 2020.February 03, 2020 correction: the results for the sample from (b)(6) 2019 and (b)(6) 2020 were incorrect in the initial report due to a typographical error.The correct results are as follows: atellica im (sn (b)(6)) positive results: date: result: (b)(6) 2019 , 338.3.(b)(6) 2020, 305.5.February 17, 2020 additional information: the customer has tested with the atellica im toxoplasma igg lot 252 from (b)(6) to (b)(6).This is the distribution of all the samples: nonreactive: 6599 patients.Equivocal: 201 patients.Reactive: 1162 patients.Siemens healthcare diagnostics has requested the patient sample for further testing and investigation.Mdr 1219913-2020-00026 supplemental report 1 and mdr 1219913-2020-00027 supplemental report 1 were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00025 on january 31, 2020.Siemens filed the mdr 1219913-2020-00025 supplemental report 1 on february 27, 2020.Siemens filed the mdr 1219913-2020-00025 supplemental report 2 on may 13, 2020.June 26, 2020 additional information: siemens did not have sufficient sample volume to further investigate this patient sample.The calculated specificity for this customer is: 6599/ 6600= 0.999 x100= 99.98%.According to the atellica im toxo g instructions for use 10995430_en rev.02, 2019-08, the relative specificity is 99.6 %.The customer has not reported any new incidents of false reactive toxo g results and this issue is considered to be an isolated and sample specific incident.Based on the available information atellica im toxo g lot 252 is performing as intended and a product performance issue has not been identified.The instrument is performing within specifications.No further evaluation of the device is required.Section h6, the device, method, results and conclusion codes were updated to reflect the additional information.Mdr 1219913-2020-00026 supplemental report 3 and mdr 1219913-2020-00027 supplemental report 3 were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00025 on january 31, 2020.Siemens filed the mdr 1219913-2020-00025 supplemental report 1 on february 27, 2020.Siemens filed the mdr 1219913-2020-00025 supplemental report 2 on may 13, 2020.Siemens filed the mdr 1219913-2020-00025 supplemental report 3 on july 20, 2020.July 28, 2020 correction: in the mdr 1219913-2020-00025 supplemental report 2, section h10, two typographical errors were noted in the patient data for sas (siemens analytics services).The equivocal % calculation should be 1.09% for lot 252 and not 10.9% and the statement "lot 258 recovery is comparable with the other lots" should state lot 252 instead of 258.The following is the correct information: lots: 247, 249, 251, 252, 258.Non-reactive: 7790 (85.94%), 8558 (79.35%), 41866 (82.95%), 115616 (85.15%), 28892 (86.09%).Equivocal: 116 (1.28%), 101 (0.94%), 708 (1.4%), 1480 (1.09%), 290 (0.86%).Reactive: 1158 (12.78%), 2126 (19.7%), 7897 (15.65%), 18591 (13.69%), 4380 (13.05%).Total: 9064, 10785, 50471, 135778, 33562.Lot 252 recovery is comparable with the other lots.The instrument is performing within specifications.No further evaluation of the device is required.Section h6, the device, method, results and conclusion codes were updated to reflect the additional information.Mdr 1219913-2020-00026 supplemental report 4 and mdr 1219913-2020-00027 supplemental report 4 were filed for the same event.

• Brand Name: ATELLICA IM TOXOPLASMA IGG (TOXO G)
• Type of Device: TOXOPLASMA GONDII IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9656119
• MDR Text Key: 203688543
• Report Number: 1219913-2020-00025
• Device Sequence Number: 1
• Product Code: LGD
• UDI-Device Identifier: 00630414600123
• UDI-Public: 00630414600123
• Combination Product (y/n): N
• PMA/PMN Number: K012183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995699
• Device Lot Number: 42017252
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR