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 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report discordant, non-reactive atellica im sars-cov-2 igg (scovg) results were obtained from two patients that were considered discordant compared to two alternative method results.Qc was in range at the time of testing.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 non-reactive 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).Siemens healthcare diagnostics is investigating.

Event Description

The customer observed atellica im sars-cov-2 igg (scovg) non-reactive (negative) results from two samples that were considered discordant compared to two alternate methods.The results were questioned by the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, non-reactive atellica im sars-cov-2 igg (scovg) results.

Manufacturer Narrative

Mdr 1219913-2022-00090 was filed on march 21, 2022.Additional information/correction - april 8, 2022: an outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report discordant, nonreactive atellica im sars-cov-2 igg (scovg) results were obtained from two patients that were considered discordant compared to two alternative method results.The customer clarified the original results and provided additional results.Patient #1 sid (b)(6): correction: atellica im scovg: <11 bau/ml (cut-off 28 bau/ml) - the customer originally stated that the results was <15 bau/ml.Patient #2 sid (b)(6): correction: atellica im scovg: <11 bau/ml (cut-off 28 bau/ml) - the customer originally stated that the results was <15 bau/ml.For troubleshooting, the sample was tested again on atellica im scovg on (b)(6) 2022 with reagent lot 013 and resulted as 0.33 index (7.2 bau/ml).Additional information - (b)(6) 2022: two patients were reported negative on the atellica im scovg but positive on alternate methods.No pcr data or date of initial diagnosis was available.One patient which was originally tested with lot 012 , which is now expired was repeated on lot 013 and the result was still negative.Per the summary and explanation section of the instructions for use (ifu) 11207632_en rev.04, 2022-01, "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." furthermore, the limitations section states: "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.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.".There is no sample left to test , root cause can not be determined.In house data was reviewed and all release criteria was met.Siemens continues to test variants and there has been no data generated indicating we are not picking up all variants.There has been no product non conformance identified.

• 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 memishian ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13846802
• MDR Text Key: 289209318
• Report Number: 1219913-2022-00090
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• 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: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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