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 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating.Siemens went on site and initially observed that the monthly cleaning procedure (mcp) was overdue.Mcp was completed.Hardware checks were also performed; simenes cleaned up the sample dispense port= ok.- checked acid and base dispense test = ok.- performed empty and fill ring = ok.An applications specialist reviewed the data and made the following observations: a review of the data provided by the customer showed the following: total weakly reactive % are high before mcp cleaning and drastically reduced after monthly maintenance performed and the same reflection are seen in sample comparison especially sid (b)(6) cov2t is reported as 8.07 on centaur s/n (b)(4) with reagent lot 005 found two replicates of negative qc results during precision study are erratic ( 3.267 and 2.895 instead mean index valve 0.37) and it is was done before service call.Date: (b)(6) 2020, % of total weakly reactive in reagent lot 005 before mcp cleaning: 24.40%, after mcp cleaning: 2.30%; (b)(6) 2020, 28.50%, 5.20%.A study was performed comparing advia centaur cov2t reagent lot 003 to 005.Date: (b)(6) 2020, reagent lot 005: 15.60%, reagent lot 003: 0.4 % (repeated on (b)(6) 2020); (b)(6) 2020, 0.60%.The increasing weakly reactive % might be due to system contamination and sample probe alignment and dispense and aspiration performance.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).Mdr 1219913-2020-00601 was filed for patient samples generated at the same site on a different day.

Event Description

The customer observed reactive (positive) advia centaur xp sars-cov-2 total (cov2t) results for a large number of patients that were nonreactive (negative) upon repeat testing on two different days of testing.The customer reported reactive (positive) results to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant cov2t results.

Manufacturer Narrative

Mdr 1219913-2020-00602 was filed on december 14, 2020.Additional information february 11, 2021: advia centaur xp sars-cov-2 total (cov2t) lot 709005 and 709007 non-reproducible reactive results observed.Siemens reviewed system logs.Multiple systems did not have monthly cleaning performed for 4 months.Sample handling was reviewed.Samples are stored in an air conditioned room (room temperature).The advia centaur xp/xpt sars-cov-2 total (cov2t) ifu (11206926_en rev.01, 2020-05) states "test specimens as soon as possible after collecting.Store specimens at 2-8c if not tested immediately within 8 hours.Freeze samples, devoid of red blood cells at -20c for longer storage".The account is no longer performing the assay.Siemens is unable to determine if assay performance and observation of non-reproducible reactive samples has improved after service.No product non-conformance identified.No further action is needed.Mdr 1219913-2020-00601 supplemental 1 was filed for patient samples generated at the same site on a different day.

• 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: 11008867
• MDR Text Key: 247656355
• Report Number: 1219913-2020-00602
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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: 11206922
• Device Lot Number: 005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1