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 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

No details on the patient receiving a second vaccine dose.Testing was performed to determine if the patient has developed antibodies after vaccination.The sinovac vaccine is a 2-dose vaccine given intramuscularly within 2-4 weeks between the first and second dose.The first dose typically called the priming dose may not generate enough of a strong antibody response when one dose is given.It is highly recommended for patients to obtain the second dose of the vaccine to obtain the higher concentration of the antibodies required to promote an even stronger protection or antibody response.The second vaccine is typically referred to as the boosting dose.The scovg and cov2t assays may not always correlate.The scovg method measures igg antibodies and the cov2t method detects igg and igm antibodies.A nonreactive test result does not exclude the possibility of exposure to or infection with sars-cov-2.It is currently unknown how long sars-cov-2 antibodies persist following infection and if the presence of antibodies confers protective immunity.Patient specimens may be nonreactive if collected during the early (pre seroconversion) 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.Results should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings.No product non-conformance identified.No further evaluation of the device is required.The atellica im scovg ifu states in the limitations section: "performance characteristics have not been established for the assay used in conjunction with other manufacturers' assays for specific sars-cov-2 serological markers.Laboratories are responsible for establishing their own performance characteristics.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).

Event Description

The customer obtained nonreactive (negative) atellica im sars-cov-2 igg (scovg) results for samples from twelve patients that were considered discordant when compared to the atellica im sars-cov-2 total (cov2t) reactive (positive) results for the time frame 2021-08-30 to 2021-09-02.Seven of the patient samples were tested on an alternate method and all of the results were positive.All the patients were vaccinated with sinovac about 2-3 months ago.There are no known reports of patient intervention or adverse health consequences due to the discordant scovg results.

• 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; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 7372808688
• MDR Report Key: 12485366
• MDR Text Key: 271914676
• Report Number: 1219913-2021-00449
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: AL
• PMA/PMN Number: EUA202669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2021
• Device Model Number: N/A
• Device Catalogue Number: 11207386
• Device Lot Number: 010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1