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 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

The atellica im scovg ifu states in the limitations section: "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).Siemens healthcare diagnostics is investigating.

Event Description

The customer obtained nonreactive (negative) atellica im sars-cov-2 igg (scovg) results for samples from six patients that were considered discordant when compared to the atellca im sars-cov-2 total (cov2t) reactive (positive) results.The customer reported the nonreactive scovg and reactive cov2t.There are no known reports of patient intervention or adverse health consequences due to the discordant scovg results.

Manufacturer Narrative

Siemens filed the initial mdr on july 27, 2021.September 15, 2021 additional information: siemens healthcare diagnostics investigated.A sample resulted non-reactive with the atellica im sars-cov-2 igg (scovg) lot 006 and reactive with cov2t lot 010.Siemens requested additional information multiple times and no response or additional information was provided.The patient symptomology and pcr information were not provided.The scovg and cov2t may not always correlate.The scovg 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.

• 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
• MDR Report Key: 12232249
• MDR Text Key: 264126863
• Report Number: 1219913-2021-00385
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: EUA202669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 11207386
• Device Lot Number: 006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1