MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR 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 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Qc was in range.Siemens reviewed sample handling with the customer: samples are run the same day they are drawn in sst tubes.Samples are spun for 10 min at 3500, then serum is separated.If the result is positive, the sample is respun at 2300 for 3 minutes and re run.Siemens continues to investigate.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).

Event Description

The customer observed a reactive (positive) advia centaur xp sars-cov-2 total (cov2t) result for 1 patient which was considered discordant to a nonreactive (negative) replicate and a negative pcr result.The customer did not report the reactive (positive) result.There are no reports of patient intervention or adverse health consequences due to the discordant cov2t result.

Manufacturer Narrative

Mdr 1219913-2020-00648 was filed on december 18, 2020.Additional information - april 15, 2021.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 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
• MDR Report Key: 11041153
• MDR Text Key: 247460172
• Report Number: 1219913-2020-00648
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1