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

Mdr 1219913-2020-00679 was filed on december 28, 2020.Additional information - january 11 2021 the following information was provided: this instrument was not serviced by a third party.The patient sample results were not reported to the physician(s).Cov2t lot 709003 was included in testing performed as part of the investigation of atellica im and advia centaur sars-cov-2 total (cov2t) non-reproducible false reactive results with lots 709004, 709005, 709006, 709035.Cov2t lot 709003 variability and discordant frequency is 1.22% compared to cov2t lots 709005/709035 is 3.37%.The customer reported a frequency of discordant results of 1.07%.Siemens continues to investigate.

Manufacturer Narrative

Mdr 1219913-2020-00679 was filed on december 28, 2020 and mdr 1219913-2020-00679 supplemental 1 was filed on february 4 2021.Additional information - february 24, 2021 advia centaur xpt sars-cov-2 total (cov2t) lot 709003 non-reproducible reactive results observed.The account's frequency of observed non-reproducible results is 1.07%.Advia centaur cov2t lot 709003 was reviewed internally for discordant results.Advia centaur cov2t lot 709003 variability and discordant frequency as obtained from siemens remote services (srs) data is 1.22% at the time of review as compared to other lots.Siemens review determined that although non-reproducible false reactive results were observed with multiple kit lots, they are performing within claims and a change in performance has not been confirmed.No product non-conformance was identified.Customer is operational.No further action is needed.

Manufacturer Narrative

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 two other nonreactive (negative) replicates.It is unknown if the customer reported the reactive (positive) result.There are no reports of patient intervention or adverse health consequences due to the discordant cov2t result.

• 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: 11076916
• MDR Text Key: 238885092
• Report Number: 1219913-2020-00679
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 03/08/2021

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: 05/12/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206710
• Device Lot Number: 003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1