MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT SARS-COV-2 IGG (COV2G); 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 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

The calibration was acceptable, and the quality control (qc) results were within the range.The limitations section of the instructions for use states: "performance characteristics have not been established for the assay used in conjunction with other manufacturers' assays for specific sars-cov-2 serological markers.Laboratories are responsible for establishing their own performance characteristics.Results obtained with the assay may not be used interchangeably with values obtained with different manufacturers' test methods.A negative result for an individual subject indicates absence of detectable anti-sars-cov-2 antibodies.Negative results do not preclude sars-cov-2 infection and should not be used as the sole basis for patient management decisions.A negative result can occur if the quantity of the anti-sars-cov-2 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.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 false negative/nonreactive 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.

Event Description

The customer obtained a nonreactive (negative) advia centaur xpt sars-cov-2 igg (cov2g) result for a patient sample.The nonreactive (negative) result was considered discordant when compared to the reactive (positive) result obtained from an alternate method.The customer reported the nonreactive (negative) result to the physician.The physician questioned the result as this did not match the clinical picture of the patient.There are no known reports of patient intervention or adverse health consequences due to the discordant cov2g result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2021-00412 on august 10, 2021.August 11, 2021 additional information: the patient was diagnosed with covid two to three weeks prior to their blood being drawn for cov2g testing.The patient was drawn on (b)(6) 2021.No pcr results are availbale for the collection date of (b)(6) 2021.Siemens healthcare diagnostics investigated.Pcr results are not available.The samples were collected 2-3 weeks after the patient was officially being diagnosed with covid.There is not an expectation the siemens cov2g assay correlates with all serology methods due to different antigens being used, different specificities and sensitivities of the serology methods and the assay architecture.Negative results do not preclude sars-cov-2 infection and should not be used as the sole basis for patient management decisions.A negative result can occur if the quantity of the anti-sars-cov-2 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.Sars-cov-2 antibodies may not be detectable in patients with recent infections (7-10 days or less) or in samples collected from patients less than 7 days from a positive polymerase chain reaction (pcr) result.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.Based on the information provided, no product problem identified.No further evaluation of the device is required.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR XPT SARS-COV-2 IGG (COV2G)
• Type of Device: SARS-COV-2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 12301205
• MDR Text Key: 265825497
• Report Number: 1219913-2021-00412
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: EUA201697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206992
• Device Lot Number: 007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1