MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM BR 27.29 (BR); BR IMMUNOASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 01/14/2022

Event Type  malfunction  

Manufacturer Narrative

A u.S.Customer observed a discordant, elevated atellica im br 27.29 (br) result relative to repeat-testing of the sample.Siemens is investigating.The instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the instructions for use states the following: "warning: do not use the atellica im br assay as a screening test or for diagnosis." "note: do not interpret levels of ca 27.29 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 27.29 within the range observed in healthy individuals.Additionally, elevated levels of ca 27.29 can be observed in patients with nonmalignant diseases.Measurements of ca 27.29 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.".

Event Description

A customer reported observation of a discordant, elevated atellica im br 27.29 (br) result.An initial elevated result was questioned by the physician, and repeat-testing of the same sample was performed using the same method on a different instrument.The first repeat result obtained was lower, and considered correct; this result was reported to the physician.There are no reports of patient intervention or adverse health consequences due to the discordant atellica im br result.

Manufacturer Narrative

Mdr 1219913-2022-00046 was submitted on 2022-02-01.Correction: in the initial report, g3 (date received by manufacturer) was incorrectly indicated as 2022-01-26.The correct date is 2022-01-25.Additional information, 2022-03-11: siemens has concluded the investigation.A u.S.Customer reported observation of a discordant, elevated atellica im br 27.29 (br) result which was not reproducible upon repeat testing using a different atellica im system.Siemens' review of customer data did not indicate any causes related to assay calibration or reagents.The customer uses four atellica im instruments to run the br assay; three of these instruments were serviced.Following the instrument service, precision was improved for two of the instruments, making precision performance similar for the four analyzers.Siemens performed a study involving lot-261 reagents returned from the customer as well as reagents from the same lot retained by siemens.Similar performance was demonstrated, indicating no evidence of a reagent shipping/handling issue.The study showed that atellica im br 27.29 (br), lot 261, is working as intended.The cause(s) of the observed result variability when using atellica im br 27.29 (br) kit lot 261 could not be determined but siemens cannot rule out pre-analytical factors, sample issues, normal assay performance, or an issue resolved with routine instrument troubleshooting.No product issues were identified, and the customer is operational.No further investigation is required.Note: in section h6, the codes for type of investigation, investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM BR 27.29 (BR)
• Type of Device: BR 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: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13417363
• MDR Text Key: 295799571
• Report Number: 1219913-2022-00046
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414598048
• UDI-Public: 00630414598048
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995477
• Device Lot Number: 261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2021
• 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