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

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

The ifu states in the limitations section: "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 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 negative/non-reactive 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 is investigating.Mdr 1219913-2021-00379 was filed for the initial result obtained on (b)(6) 2021 on analyzer #1.Mdr 1219913-2021-00380 was filed for the repeat result obtained on (b)(6) 2021 on analyzer #2.

Event Description

A customer is questioning advia centaur xpt sars-cov-2 total (cov2t) non-reactive (negative) results obtained when testing different samples from one patient.The customer believes the non-reactive (negative) results to be discordant when compared to reactive results obtained using the advia centaur xpt scovg assay and an alternate test method.The initial non-reactive cov2t result was reported; it is unknown if the result was questioned by the physician.A corrected result was not provided.There are no known reports of patient intervention or adverse health consequences due to the discordant cov2t results.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2021-00381 initial report on july 20, 2021.Additional information - 2021-08-03: siemens has concluded investigation for a customer observation of non-reactive (negative) advia centaur xpt sars-cov-2 total (cov2t) results from one patient compared to the reactive results obtained with scovg and another alternate method.Information regarding whether pcr testing was performed is not available.The vaccination status or other patient information is not available.The advia centaur cov2t and scovg assays may not always correlate.The scovg method measures igg antibodies and the cov2t method detects igg and igm antibodies.There is not an expectation that the cov2t assay correlates with all serology methods due to different antigens being used, different specificities and sensitivities of the serology methods and the assay architecture.No product problem was identified.Customer is operational.No further action is needed.Mdr 1219913-2021-00379 supplemental 1 report was filed for the initial result obtained on (b)(6) 2021 on analyzer #1.Mdr 1219913-2021-00380 supplemental 1 report was filed for the repeat result obtained on (b)(6) 2021 on analyzer #2.

• Brand Name: ADVIA CENTAUR XPT SARS-COV-2 TOTAL (COV2T)
• Type of Device: SARS-COV-2 TOTAL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12198196
• MDR Text Key: 280812940
• Report Number: 1219913-2021-00381
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206922
• Device Lot Number: 010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR