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

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 11/28/2021

Event Type  malfunction  

Manufacturer Narrative

A us customer observed a discordant depressed atellica im 1600 br (br 27.29) result for a patient sample compared to replicate testing.Siemens is investigating.The instructions for use (ifu) states in the interpretation of results section: "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: "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

Customer observed a discordant depressed atellica im 1600 br (br 27.29) result for a patient sample compared to other replicates.The results were reported to the physician and were not questioned.A ct scan was performed.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant br depressed result.

Manufacturer Narrative

The initial mdr, was filed on 6 january 2022.14 april 2022 - additional information.A united states (us) customer observed a discordant depressed atellica im 1600 br (br 27.29) result for a patient sample compared to other replicates.For sample (b)(6) the lower result does not appear to be associated with low qc recovery indicating the difference in sample recovery is most likely due to the sample itself rather than the assay or analyzer.Atellica im br kit lot 259 expired 2022/01/14, so no internal studies were done with the lot, and the customer moved to atellica im br kit lot 261 in early december.A search of the complaint database found no other complaints about atellica im br kit lot 259.A review of internal data indicates atellica im br kit lot 259 is performing as intended.The cause(s) of the variability of patient sample recovery run to run seen by the customer when using atellica im br kit lot 259 could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.The customer is operational.No further action is needed.This support task investigation is complete.In section h6, the investigation findings and investigation conclusion codes were updated to reflect the investigation results.

• Brand Name: ATELLICA IM BR CA 27.29
• 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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 13174702
• MDR Text Key: 289523316
• Report Number: 1219913-2022-00007
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995477
• Device Lot Number: 259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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