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

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00624 on december 14, 2020.January 07, 2021 additional information: siemens healthcare diagnostics has investigated.The investigation determined that although non-reproducible false reactive results were observed, results indicate the negative percent agreement confidence interval of the kit lots evaluated overlap the confidence interval in the ifu; therefore the atellica im sars-cov-2 total (cov2t) lot 001 is performing within claims and a change in performance has not been confirmed.No product non-conformance has been identified.No further evaluation of the device is required.

Manufacturer Narrative

The quality control (qc) was in range.After the initial result was reported, the sample was stored inside the rsm module on the aptio track overnight.The sample was retrieved from storage the next morning to begin the lot to lot correlation study.There had been no hardware issues with the storage module, so it is assumed the sample was at refrigerated temperature when run for this purpose.The sample then sat on the sample handler for approximately 1 hour when it was run on lot 001 for 4 additional replicates.The ifu states in the limitations section: "this assay should not be used to diagnose or exclude acute infection.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 reactive test result does not exclude past or present infection by other coronaviruses, such as sars-cov-1, mers-cov, hku1, 229e, nl63, or oc43." a false positive/reactive result would not be used in isolation and would be correlated with clinical history.Additional laboratory testing would be used to determine specific antibody presence.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 reactive (positive) atellica im sars-cov-2 total (cov2t) result for a patient that was considered discordant with the nonreactive (negative) results from a correlation study.The correlation study was between reagent lot 001 and reagent lot 007.The patient sample was repeated with reagent lot 001 and all the results were nonreactive (negative).There are no known reports of patient intervention or adverse health consequences due to the discordant cov2t result.

• Brand Name: ATELLICA IM SARS-COV-2 TOTAL (COV2T)
• 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 ; 5086604603
• MDR Report Key: 11002432
• MDR Text Key: 234094483
• Report Number: 1219913-2020-00624
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA201367
• 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,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206711
• Device Lot Number: 001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1