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 Positive Result (1227)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center to report an observation of a positive (reactive) advia centaur xpt sars-cov-2 igg (scovg) result that was discordant to alternate test methods.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." "it is currently unknown how long sars-cov-2 antibodies persist following infection and if the presence of antibodies confers protective immunity." a false positive/reactive result would not be used in isolation and would be correlated with clinical history.At this time, the presence of an immune response cannot be interpreted as confirmation of immunity.Thus, continued precautions to avoid infection will occur 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.

Event Description

A customer reported a positive (reactive) advia centaur xpt sars-cov-2 igg (scovg) result that was discordant to alternate methods.The customer indicated that the initial result was provided to the physician and were questioned and that a corrected report was issued.There are no reports of patient intervention or adverse health consequences due to the positive (reactive) scovg result.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2021-000524 initial report on 2021-12-30.Additional information - 2022-04-18.Siemens has concluded investigation for a customer observation of a positive (reactive) advia centaur xpt sars-cov-2 igg (scovg) result with lot 012 that was discordant to alternate methods.Complaint lot 012 has since expired, therefore further testing cannot be performed.For the alleged false positive advia centaur xpt scovg sample result, data provided was inconclusive to whether the sample was reactive on scovg as the numeric result indicated a reactive result, but the interpretation provided by the customer was negative.The sample was not repeated on the scovg assay.As per the advia centaur xpt scovg ifu 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." 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: 13118156
• MDR Text Key: 289762928
• Report Number: 1219913-2021-00524
• 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: 04/20/2022

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: 04/18/2022
• 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