MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM SARS-COV-2 IGG (SCOVG); SARS-COV-2 IMMUNOASSAY

Model Number N/A

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

A customer from outside of the united states observed discordant nonreactive (negative) results when using the atellica im sars-cov-2 igg (scovg) assay.The atellica im sars-cov-2 igg (scovg) instructions for use (ifu) states the following, under limitations: "results obtained with the assay may not be used interchangeably with values obtained with different manufacturers' test methods." "results are not intended to be used as the sole basis for patient management decisions.Test results should be interpreted in conjunction with clinical observations, patient history, epidemiological information, and other laboratory findings." "a nonreactive test result does not exclude the possibility of exposure to or infection with sars-cov-2.Patient specimens may be nonreactive if collected during the early (preseroconversion) phase of illness or due to a decline in titer over time.In addition, the immune response may be depressed in elderly, immunocompromised, or immunosuppressed patients." a false negative/non-reactive result would be correlated with clinical history and presentation and may lead to additional testing and/or continued precautions to avoid infection with negligible clinical impact.Although there is no potential for serious injury in this case, an mdr will be reported to the fda as a requirement of the emergency use authorization (eua).Mdrs 1219913-2022-00025 and 1219913-2022-00026 were filed for the same event.

Event Description

The customer reports repeat observations of discordant nonreactive (negative) results for one patient when tested on two different days using the atellica im sars-cov-2 igg (scovg) assay.The atellica im scovg results were discordant relative to positive results produced using two alternate methods and a new sample from the same patient.The new sample was also tested using advia centaur scovg, and produced a nonreactive (negative) result.The positive results produced by the alternate test methods were considered correct, due to the patient's known vaccination history.There are no reports of patient intervention or adverse health consequences due to the discordant scovg results.

Manufacturer Narrative

Mdr 1219912-2022-00024 was filed on 2022-01-26.Corrections: 1) date of 2nd vaccination was incorrectly listed as (b)(6) 2021 instead of (b)(6) 2021 in section b7 of the original report.Section b7 of this report has been updated with the correct 2nd vaccination date of (b)(6) 2021.2) date of manufacture had been incorrectly reported as 07-oct-2021, and has been corrected to 14-sep-2021 in h4.Additional information, 2022-03-31: siemens has concluded the investigation.A customer from outside the u.S.Observed reproducible nonreactive (negative) atellica im sars-cov-2 igg (scovg) results for one patient which were discordant relative to alternate-method testing.Siemens received a sample from the affected patient, returned by the customer.The sample was tested using the atellica im cov2t assay, in addition to two alternate methods.Negative results were obtained using all of these methods, agreeing with the observed nonreactive results.It is noted that the alternate methods used by the customer target the trimeric sars-cov-2 full spike protein.Both siemens and the alternate methods tested use an s1 rbd target.Comparison of results between assays with different protein targets may not be appropriate as the assays will be expected to respond differently depending on the capture antigen used.The assay's instructions for use (ifu) states that "multiple covid-19 vaccines target or include the s1 rbd, as data indicate antibodies to this region can be neutralizing.The ability to identify specific antibodies associated with neutralization is an important adjunct to the detection of an immune response to the sars-cov-2 virus." the following are also noted, under limitations: "it is currently unknown how long sars-cov-2 antibodies persist following infection and if the presence of antibodies confers protective immunity." "a nonreactive test result does not exclude the possibility of exposure to or infection with sars-cov-2.Patient specimens may be nonreactive if collected during the early (preseroconversion) phase of illness or due to a decline in titer over time.In addition, the immune response may be depressed in elderly, immunocompromised, or immunosuppressed patients." no further testing of the specimen can be performed.In testing, the assay met its performance specifications, and no product nonconformance was identified.The customer is operational; no further investigation is required.Notes: 1) in section h6, the codes for type of investigation, investigation findings and investigation conclusion have been updated.2) mdrs 1219913-2022-00025 and 1219913-2022-00026 were filed for the same event.

• Brand Name: ATELLICA IM SARS-COV-2 IGG (SCOVG)
• Type of Device: SARS-COV-2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13358361
• MDR Text Key: 295605953
• Report Number: 1219913-2022-00024
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EUA202669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Model Number: N/A
• Device Catalogue Number: 11207386
• Device Lot Number: 012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female