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 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

Qc was in range.The system has been inspected by a siemens' customer service engineer.Maintenance is up to date.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.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 obtained reactive (positive) advia centaur xp sars-cov-2 total (cov2t) results for three patients.The initial reactive (positive) results were considered discordant when compared to the nonreactive (negative) repeat results.The customer did not report the results.There are no known reports of patient intervention or adverse health consequences due to the discordant cov2t results.

Manufacturer Narrative

Mdr 1219913-2020-00684 was filed on december 29 2020.Additional information - january 4, 2021: the customer provided the following information on patient 3: the pcr on the patient was done on (b)(6) 2020, pcr was positive.The patient came in through the emergency room.Siemens continues to investigate.

Manufacturer Narrative

Mdr 1219913-2020-00684 was filed on december 29, 2020 and mdr 1219913-2020-00684 supplemental 1 was filed on january 25 2021.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.

• 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
• 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: 11086185
• MDR Text Key: 247630646
• Report Number: 1219913-2020-00684
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA201370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1