MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP SARS-COV-2 IGG (COV2G); SARS-COV-2 IMMUNOASSAY

Model Number N/A

Device Problems False Negative Result (1225); False Positive Result (1227)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

The quality control (qc) results were within the range.The customer is running in random access mode off aptio track.Both patient samples were fresh draws run within 3 hours of collection.The patient samples were spun for 30 minutes.The ifu states in the limitations section: "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).Siemens healthcare diagnostics is investigating.Mdrs 1219913-2020-00622 was filed for different testing date.

Event Description

The customer obtained reactive (positive) advia centaur xp sars-cov-2 total (cov2t) results for two samples from the same patient on different dates.The results were considered discordant with the cov2g nonreactive (negative) results for both samples.The patient had a pcr positive result in the beginning of (b)(6) 2020.The advia centaur xp results were reported to the physician and questioned.There are no known reports of patient intervention or adverse health consequences due to the discordant cov2t results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00623 on december 14, 2020.December 15, 2020 additional information: the customer states the cov2g nonreactive (negative) results are considered discordant as the laboratory is expecting the patient to be positive.The antigen testing for the patient was positive in (b)(6).The brand name information (advia centaur xp sars-cov-2 igg (cov2g)).The common device name information (sars-cov-2 immunoassay).The suspect medical device name (information for cov2g assay).Catalog number 11206992, lot number 004, expiration date 03/10/2021, udi number (b)(4).Pma/510k number ((b)(4)).The device manufacturer date (08/04/2020).Advia centaur xp sars-cov-2 total (cov2t) lot 002 cov2t sample result was reactive and non-reactive with cov2g assay.The cov2g and cov2t may not always correlate.The cov2g method measure igg antibodies and the cov2t method detects igg and igm antibodies.The cov2t is more sensitive than the cov2g method.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.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 should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings.Based on the information provided siemens did not identify a product problem.No further evaluation of the device is required.Mdrs 1219913-2020-00622 supplemental report 1 was filed for different testing date.

• Brand Name: ADVIA CENTAUR XP 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 11002431
• MDR Text Key: 247428662
• Report Number: 1219913-2020-00623
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA201697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206992
• Device Lot Number: 004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 20 YR