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

Model Number N/A

Device Problem False Positive Result (1227)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens reviewed siemens remote services (srs) atellica im patient data from 07 mar.2019 to june 26th, 2020.Atellica im txog lot 258 is recovering similarly with other lots with respect to the number of negative, equivocal and positive results observed in the testing population.(b)(6).Siemens is continuing to investigate.The limitations section of the instructions for use states: "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.".

Event Description

Customer observed a positive atellica im 1300 toxoplasma g (toxog) result on a sample that resulted negative on an alternate method.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, reactive atellica im 1300 toxog result.

Manufacturer Narrative

Siemens healthcare diagnostics filed initial mdr 1219913-2020-00175 on july 10, 2020.Additional information 08/28/2020: the customer provided the total number of negative samples tested with aim toxoplasma igg kit lot 258 and 260 (105 samples).Based on this, siemens calculated % specificity of both lots combined as 99.1%.The customer is waiting for hbt/nabt tubes to test as suggested by siemens.The patient was pregnant and the sample tested was obtained on the day of delivery.Siemens continues to investigate.

Manufacturer Narrative

Siemens healthcare diagnostics filed initial mdr 1219913-2020-00175 on july 10, 2020 and mdr 1219913-2020-00175 supplemental 1 report on september 26, 2020 for a false positive atellica im toxoplasma igg (toxo g) result.Additional information 09/26/2020: siemens completed an internal study on atellica im system for toxoplasma igg (toxo g) assay.During the study toxo g reagent lots 258, 260 and 262 were used.Toxo g reagent lot 252 expired on august 9th, 2020 and was relabeled to reagent lot 997.Results generated with lot 997 were solely for informational purposes.Fifty (50) normal patient samples from siemens and fifty (50) patient samples from france were tested in replicates of 3 (n=3).The final interpretation was the same for all 50 samples from france and for 49/50 patient samples from siemens.The one siemens normal patient sample was reactive with reagent lots 997, 258 and 260 and equivocal with reagent lot 262.This is a cut off sample (10.0 iu/ml) and recovery was within acceptable precision at that level.Siemens continues to investigate.

Manufacturer Narrative

Siemens healthcare diagnostics filed initial mdr on july 10, 2020 and mdr supplemental 1 report on september 23, 2020 and mdr supplemental 2 report on october 29, 2020 for a false positive atellica im toxoplasma igg (toxo g) result.Investigation results from 10/26/2020: siemens has concluded the investigation for a false reactive result on one patient sample on atellica im toxoplasma igg (toxo g) lot 258 versus an alternate test method.Siemens reviewed the customer's calibration data and it was comparable to lot release data.Siemens quality control was within expected range.Atellica im toxoplasma igg (toxo g) siemens analytics service (sas) patient data from march 2019 to june 2020 and toxo g lot 260 recovered similarly for interpretation rates with the previous lots.Siemens reviewed internal data for mean control recovery comparing lots 252 to 258, and lots 258 to 260, which showed the same trend; lot 258 was elevated compared to lots 252 and 260.Further analysis of the sas data for mean patient recovery across several reagent lots verified that lot 258 was elevated compared to lots 252 and 260 globally and in france.The atellica im toxoplasma igg (toxo g) instructions for use (ifu) (b)(4) rev.02, 2019-08 interpretation of results section states, "the magnitude of the measured result above the cut-off value is not indicative of the total amount of antibody present in the sample." siemens initiated an internal study that included toxo g lots 258, 260 and 262, fifty (50) normal patient samples from siemens and fifty (50) patient samples from france.The patient samples from france for the internal study were purchased by siemens from an approved supplier and french acquisition company (inospecimens niobank).All samples were tested in replicates of 3 (n=3).The final interpretation was the same for all patient samples across all reagent lots, with the exception of 1 sample from siemens.That sample was near the cutoff of 10 iu/ml and recovery was within acceptable precision at that level.Based on information provided, the calculated specificity for this account is 105/106= 0.9906 x100 = 99.1%.The atellica im toxoplasma igg (toxo g) instructions for use (ifu) initial relative specificity results from the 3 studies range from 97.7%- 99.8%.Atellica im toxoplasma igg lot 061258 is performing as intended.Heterophilic blocking tube (hbt) to the customer for additional testing of the sample, but results were not provided.If more information or sample becomes available a new escalation will be opened, providing all requested information and patient samples.The customer is operational.Based on the available information and a product performance issue has not been identified.No further evaluation of the device is required.The investigation findings and conclusion codes have been updated to reflect the investigation results.Reference section h6 of this report for the final codes for this event.

• Brand Name: ATELLICA IM TOXOPLASMA G (TOXOG)
• Type of Device: TOXOPLASMA GONDII IMMUNOASSAY,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10261069
• MDR Text Key: 218999953
• Report Number: 1219913-2020-00175
• 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
• Report Date: 11/19/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995699
• Device Lot Number: 258
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 09/26/2020; 10/26/2020
• Supplement Dates FDA Received: 09/23/2020; 10/19/2020; 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR