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 Positive Result (1227)

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, reactive (positive) results were obtained from two samples and the results were considered discordant compared to testing with an alternate method.One of these samples was also discordant to testing with a different lot of atellica im sars-cov-2 total.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) reactive (positive) results were obtained from two samples and the results were considered discordant compared to testing with an alternate method.One of these samples was also discordant to testing with a different lot of atellica im sars-cov-2 total.The reactive results were reported to the physician(s) who questioned the results.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, reactive atellica im sars-cov-2 total (cov2t) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2022-00088 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, reactive (positive) results were obtained from two samples and the results were considered discordant compared to testing with an alternate method.One of these samples was also discordant to testing with a different lot of atellica im sars-cov-2 total.Siemens healthcare diagnostics has completed the investigation into alleged differences in cov2t results compared to an alternate method and the difference of one sample 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 the root cause.No product nonconformance was identified.In section h6, the investigation finding, and investigation conclusion codes were updated.Mdr 1219913-2022-00088 supplemental 1 and mdr 1219913-2022-00089 supplemental 1 were filed for the same event.

• 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: 13831098
• MDR Text Key: 297573137
• Report Number: 1219913-2022-00088
• 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: 02/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 11206711
• Device Lot Number: 012
• 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: 05/19/2021
• 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