MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM SARS-COV-2 TOTAL (COV2T); SARS-COV-2 TOTAL IMMUNOASSAY

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report discordant, non-reactive atellica im sars-cov-2 total (cov2t) results obtained from two samples that were considered discordant compared to testing with a different lot of atellica im sars-cov-2 total and an alternate method.Qc was in range at the time of testing.The interpretation of results section of the instructions for use (ifu) states: "the system reports advia centaur cov2t assay results in index values or u/ml and as non-reactive or reactive: non-reactive: < 1.00 index (u/ml).These samples are considered negative for sars-cov-2 antibodies.Reactive:

Event Description

The customer reported atellica im sars-cov-2 total (cov2t) non-reactive (negative) results were obtained from two samples and the results were considered discordant compared to testing with a different lot of atellica im sars-cov-2 total and an alternate method.It is unknown if the non-reactive results were reported to 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 total (cov2t) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00087 on march 18, 2022.March 24, 2022, additional information: an outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report discordant, nonreactive atellica im sars-cov-2 total (cov2t) results obtained from two samples that were considered discordant compared to testing with a different lot of atellica im sars-cov-2 total and an alternate method.Siemens healthcare diagnostics has completed the investigation into alleged difference in cov2t results between lot 012 and 013.Quality control and calibrations were appropriate for both kit lots at the time of testing.In review of in-house data, there is no data that showed patients positive on lot 12 but negative on lot 13.No patient history was available, and no further testing could be conducted as the kit lot 012 had expired.This appears to be a sample-specific issue however without further medical history siemens healthcare is unable to determine root cause.It was agreed with the customer to save samples and will rerun a method comparison when this kit is close to expiry with the new kit.The root cause could not be determined.No product nonconformance was identified.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM SARS-COV-2 TOTAL (COV2T)
• Type of Device: SARS-COV-2 TOTAL 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: 13831096
• MDR Text Key: 297523298
• Report Number: 1219913-2022-00087
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EUA201367
• 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: 03/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2022
• Device Model Number: N/A
• Device Catalogue Number: 11206711
• Device Lot Number: 013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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