MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP 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 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Mdr 1219913-2020-00676 was filed on december 28, 2020.Additional information - december 30, 2020.The customer reported that this is not an isolated issue affecting only one patient, but affected many patient samples all tested with lot 005.The customer estimated rate of samples reading between 0.8 and 1.2 is >20% with lot 005, however, no data was provided.Additional information - january 4, 2021.Siemens performed an investigation with atellica im and advia centaur sars-cov-2 total (cov2t) non-reproducible false reactive results with lots 709004, 709005, 709006, 709035.The variability and discordant frequency for cov2t lots 709005/709035 was 3.37%.The account's frequency is much higher.Additional information - january 5, 2021.The customer confirmed that the same sample was used for all the results and that the sample was not re-centrifuged between testing.The customer has not reported any additional fliers since moving to cov2t lot 004.Additional information: january 25, 2021.Siemens healthcare diagnostics has concluded its investigation of atellica im and advia centaur sars-cov-2 total (cov2t) non-reproducible false reactive results with kit lots ending in 004, 005, 035 and 006.Siemens investigation determined that although non-reproducible false reactive results were observed with multiple kit lots, results indicate the negative percent agreement confidence interval of the kit lots evaluated overlap the confidence interval in the ifu; therefore they are performing within claims and a change in performance has not been confirmed.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.The advia centaur sars-cov-2 total (cov2t) lot 005 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.The investigation finding, and investigation conclusion codes were updated.Mdr 1219913-2020-00677 supplemental 1 is filed for the results from the same sample generated on the atellica im cov2t assay.

Manufacturer Narrative

Siemens reviewed the sample handling: serum collected in vacutainer sstii ref 367957.Centrifugation at room temperature at 2000g for 10 minutes.Siemens is investigating.The limitations section of the instructions for use states: "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).Mdr 1219913-2020-00677 was filed for the same sample tested on the atellica im sars-cov-2 total (cov2t) assay.

Event Description

The customer observed reactive (positive) results on the advia centaur xp sars-cov-2 total (cov2t) and atellica im sars-cov-2 total (cov2t) assays for one patient.The patient was sent for a pcr test.The pcr result for the patient was negative.The atellica im sars-cov-2 total (cov2t)reactive (positive) result was reported to the physician and was not questioned.There are no reports of patient intervention or adverse health consequences due to the discordant cov2t results.

• Brand Name: ADVIA CENTAUR XP 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; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 11076914
• MDR Text Key: 234217832
• Report Number: 1219913-2020-00676
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EUA201370
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206710
• Device Lot Number: 005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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
• Patient Age: 70 YR