MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT SARS-COV-2 TOTAL (COV2T); SARS-COV-2 IMMUNOASSAY

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

The calibration was acceptable, and the quality control (qc) results were within the range.The customer reports no issues with other assays, sample pre-analytic or sample/reagent storage.The patient sample was sent to another laboratory for confirmation testing; results are not yet available.The limitations section of the advia centaur xpt instructions for use states: "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 nonreactive test result does not exclude the possibility of exposure to or infection with sars-cov-2.Patient specimens may be nonreactive if collected during the early (preseroconversion) phase of illness or due to a decline in titer over time.In addition, the immune response may be depressed in elderly, immunocompromised, or immunosuppressed patients" a false positive result would have negligible clinical impact as management and treatment decisions are based on severity of clinical presentation and management primarily consists of supportive care.A false negative result would be correlated with clinical history and presentation and may lead to additional testing and/or continued precautions to avoid infection with negligible clinical impact.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 investigating.

Event Description

A customer obtained a reactive (positive) advia centaur xpt sars-cov-2 total (cov2t) result for a patient sample.The sample was repeated on the advia centaur xpt sars-cov-2 total (cov2t) assay after re-centrifugation and transfer into a secondary tube.One repeat result was nonreactive (negative) and the other repeat result was reactive (positive).The results were provided to physician and were questioned.There are no known reports of patient intervention or adverse health consequences due to the discordant cov2t results.

Manufacturer Narrative

Siemens filed mdr 1219913-2021-00104 initial report on february 12, 2021.Additional information - 03/31/2021 the customer sent the sample to another laboratory for testing with an alternate method; result was negative.Siemens has concluded the investigation for imprecision observed with one patient sample with advia centaur xpt sars-cov-2 total (cov2t) lot 002.A reactive (positive) advia centaur xpt sars-cov-2 total (cov2t) result for a patient sample was observed by the customer.The sample was repeated on the advia centaur xpt sars-cov-2 total (cov2t) assay after re-centrifugation and transfer into a secondary tube.One repeat result was nonreactive (negative) and the other repeat result was reactive (positive).Alternate method testing was negative.No additional information was provided.Siemens cannot rule out pre-analytical factors or sample specific issue.Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the imprecise results, a product problem was not identified.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 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: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 5086685000
• MDR Report Key: 11324938
• MDR Text Key: 244267718
• Report Number: 1219913-2021-00104
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206710
• Device Lot Number: 002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1