MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM SARS-COV-2 TOTAL (COV2T); 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 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

The calibration was acceptable, and quality control (qc) was in range.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 investigated and concluded its investigation of atellica im and advia centaur sars-cov-2 total (cov2t) non-reproducible false reactive results with kit lots ending in 004, 005, 035 and 006.Siemens investigation determined that although non-reproducible false reactive results were observed with multiple kit lots, results indicate the negative percent agreement confidence interval of the kit lots evaluated overlap the confidence interval in the ifu.Therefore, they are performing within claims and a change in performance has not been confirmed.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.The atellica im sars-cov-2 total (cov2t) lot#: 005 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.

Event Description

A customer obtained reactive (positive) atellica im sars-cov-2 total (cov2t) results for 8 different patients tested on the same day.The reactive (positive) results were considered discordant compared to the nonreactive (negative) re-test results.There are no reports of patient intervention or adverse health consequences due to the discordant cov2t results.".

• Brand Name: ATELLICA IM SARS-COV-2 TOTAL (COV2T)
• 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 ; 5086685000
• MDR Report Key: 10977611
• MDR Text Key: 220755288
• Report Number: 1219913-2020-00612
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EUA201367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2021
• Device Model Number: N/A
• Device Catalogue Number: 11206923
• Device Lot Number: 005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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