MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT 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 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

The calibration was acceptable and the quality control (qc) results were within the range.The 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 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, or due to cross-reactivity from pre-existing antibodies or other possible causes." 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

A customer obtained reactive (positive) advia centaur xpt sars-cov-2 total (cov2t) results on the same day on the same instrument for samples from four patients.The initial reactive (positive) results were considered discordant when compared to the nonreactive (negative) repeat results.Additional sample from each patient was tested for verification and all results were nonreactive (negative).Initial results were not reported to physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant cov2t results.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2021-00254 initial report on may 14, 2021.2021/05/17.In section b6 of mdr 1219913-2021-00254 initial report, filed 2021/05/14, the first date of testing of the second sample of all four patients is listed as "(b)(6) 2021".However, the actual test date is unknown.On (b)(6) 2021, the customer confirmed that the samples were processed between a date range of (b)(6) 2021 to "(b)(6) 2021.Additional information - 2021/05/18.Siemens healthcare diagnostics has concluded its investigation of atellica im and advia centaur sars-cov-2 total (cov2t) lot 007 non-reproducible false reactive (positive) results.Results of the investigation indicate that although non-reproducible false reactive (positive) results were observed, the negative percent agreement confidence interval of the kit lots evaluated overlap the confidence interval listed in the assay instructions for use (ifu); therefore, the product is performing as intended.A product performance problem has not been identified.No further evaluation of the device is required.In section h6, the investigation finding and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR XPT 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
• MDR Report Key: 11827445
• MDR Text Key: 252768328
• Report Number: 1219913-2021-00254
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: EUA201370
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206710
• Device Lot Number: 007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1