MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM SARS-COV-2 IGG (COV2G); 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 08/07/2021

Event Type  malfunction  

Manufacturer Narrative

The quality control (qc) results for both the cov2g and cov2t assays were within the range.The customer verified that there have been no issues with the qc or calibrations.The atellica im cov2g ifu states in the limitations section: "the clinical applicability of a quantitative or semi-quantitative result is currently unknown and cannot be interpreted as an indication or degree of immunity nor protection from reinfection, nor compared to other sars-cov-2 antibody assays.This device should not be used to diagnose or exclude acute sars-cov-2 infection.Direct testing for sars-cov-2 with a molecular assay should be performed to evaluate acute infection in symptomatic individuals.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 negative result for an individual subject indicates absence of detectable anti-sars-cov-2 antibodies.Negative results do not preclude sars-cov-2 infection and should not be used as the sole basis for patient management decisions.A negative result can occur if the quantity of the anti-sars-cov-2 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected." 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 obtained a nonreactive (negative) atellica im sars-cov-2 igg (cov2g) result for a patient sample that was considered discordant when compared to the reactive (positive) sars-cov-2 total (cov2t) result.The customer reported the result to the physician and the result was questioned.The patient had covid in (b)(6) 2021.There are no known reports of patient intervention or adverse health consequences due to the discordant cov2g result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2021-00427 on august 25, 2021.September 9, 2021 additional information: siemens healthcare diagnostics investigated.The patient sample is resulting non-reactive with the atellica im sars-cov-2 igg (cov2g) lot 008 and reactive with the cov2t lot 011.The patient had covid in (b)(6) 2021.There is no pcr information available.The cov2g and cov2t may not always correlate.The cov2g method measures igg antibodies and the cov2t detects igg and igm antibodies.The total antibody is more sensitive than the igg method.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 (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.Based on the information provided siemens did not identify a product problem.No further evaluation of the device is required.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM SARS-COV-2 IGG (COV2G)
• Type of Device: SARS-COV-2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12364810
• MDR Text Key: 268054050
• Report Number: 1219913-2021-00427
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: EUA201696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206997
• Device Lot Number: 008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR