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 Positive Result (1227)

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

Event Date 12/26/2021

Event Type  malfunction  

Event Description

A customer inadvertently tested 2 samples from same patient using advia centaur xpt sars-cov-2 total (cov2t).One sample resulted as positive (reactive) and the other sample resulted as negative (non-reactive).The sample that tested positive was repeated in duplicate and both results were negative, indicating the initial result from this sample was a false positive.The initial positive (reactive) result was not reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the false positive (reactive) cov2t patient result.

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center to report an observation of a false positive (reactive) advia centaur xpt sars-cov-2 total (cov2t) patient result.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 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, or due to cross-reactivity from pre-existing antibodies or other possible causes." 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.

Manufacturer Narrative

Siemens healthcare diagnostices filed mdr 1219913-2022-00011 initial report on 2022-01-20.Correction - 2022-02-04.The customer confirmed the actual test date for this event is (b)(6) 2021 and not (b)(6) 2021 as previously documented in the inital mdr report.Sections b3 and b6 of this report were corrected to include the correct test date.Additional information -2022-02-04.The instrument was not serviced by a third party.Section d8 of this report was updated with this information.Siemens service was dispatched for this event.The instrument was checked for problems and the folloing actions were taken: delivery of acid and base reagents was checked.All probes and manifold were cleaned and drips on manifold was checked.The ion electrode on fan was cleaned.Dark count and luminometer readings were checked.After service, the customer performed qc and said results were better.No further patient fliers were observed on the system since service was performed.Additional information -2022-02-08.Additional test results for the same patient were provided by the customer and added to section b6 of this report.Patient information was provided by the customer and added to sections a2, a3 and b7 of this report.Additional information -2022-02-16.Siemens reviewed the instrument and event data including service actions performed by the customer service engineer (cse).Siemens concluded that the probable cause of the discordant result could not be determined based on the variety of troubleshooting steps performed.The issue was resolved with the various troubleshooting performed as part of normal routine instrument troubleshooting.Based on the investigation, no product problem was identified with the advia centaur xpt (s/n (b)(6)).The system is operating as expected.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2022-00011 initial report on 2022-01-20 and mdr 1219913-2022-00011 supplemental 1 report on 2022-03-03.Additional information - 2022-03-29.Siemens has completed the investigation into an initial false positive (reactive) advia centaur xpt sars-cov-2 total (cov2t) result for one patient.Initially, two separate samples were drawn and both were tested for cov2t.One sample was negative and one was positive.The positive sample was then retested and repeated as negative.At the same time, a pcr test was run and yielded a positive response which would indicate early infection.It is possible that antibodies would not be detectable at the same time.Although dates were not provided from another draw from the same patient, the advia centaur cov2t result from this sample was reactive.It is likely the antibodies did start to rise as the patient progressed in their illness.Additionally, siemens is unable to rule out a preanalytical issue with the first sample and the initial reactive result.Siemens hardware support provided assessment of the initial reactive where no mechanical issues were determined to conclusively prove a mechanical deficiency.The customer has not escalated further fliers for the cov2t assay.Based on the investigation, no product problem has been identified with the advia centaur xpt instrument (s/n (b)(6)) or with cov2t reagent lot 012.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

• 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
• 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: 13308056
• MDR Text Key: 289612763
• Report Number: 1219913-2022-00011
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EUA201370
• 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,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 11206922
• Device Lot Number: 012
• Was Device Available for Evaluation?: No
• 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: 06/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female