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

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

A customer contacted siemens healthcare diagnostics to report an observation of negative (non-reactive) advia centaur xpt sars-cov-2 igg (scovg) results on multiple patient samples that were expected to be positive (reactive).The customer stated that samples were sent to other laboratories (non-customer sites) for comparison testing with alternate methods.Positive (reactive) results were obtained when the samples were tested with the alternate methods.The customer indicated that the initial results were provided to the physician(s) and were questioned and that corrected reports were issued.There are no reports of patient intervention or adverse health consequences due to the false negative (non-reactive) scovg results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center to report an observation of negative (non-reactive) advia centaur xpt sars-cov-2 igg (scovg) results on multiple patient samples that were expected to be positive (reactive).The limitations section of the instructions for use state: "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 is investigating.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2021-000523 initial report on 2021-12-30.Additional information - 2022-03-29.Siemens has concluded investigation for a customer observation of discordant advia centaur xpt sars-cov-2 igg (scovg) results with lot 012.The issue presented was lack of correlation for multiple patient samples vs alternate platforms.Complaint lot 012 has since expired, therefore further testing cannot be performed.For the alleged false negative advia centaur xpt scovg sample results, data provided was inconclusive as to which samples were affected.Samples were positive on the sars-cov-2 total (cov2t) assay which could indicate the patients were recently infected with igm more prevalent.The samples were also positive on alternate platforms.As per the advia centaur xpt scovg instructions for use (ifu) 11207491_en rev.03, 2021-09, summary and explanation section, "multiple covid-19 vaccines target or include the s1 rbd, as data indicate antibodies to this region can be neutralizing.The ability to identify specific antibodies associated with neutralization is an important adjunct to the detection of an immune response to the sars-cov-2 virus." as per the ifu in the limitations section, "it is currently unknown how long sars-cov-2 antibodies persist following infection and if the presence of antibodies confers protective immunity." "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 (pre seroconversion) 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." "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." siemens's internal data was reviewed for scovg lot 012 and all specifications were being met.No product non conformance has been identified.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ADVIA CENTAUR XPT SARS-COV-2 IGG (SCOVG)
• 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 ; 3392064073
• MDR Report Key: 13118155
• MDR Text Key: 289762663
• Report Number: 1219913-2021-00523
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EUA202670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Model Number: N/A
• Device Catalogue Number: 11207376
• Device Lot Number: 012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1