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 09/23/2021

Event Type  malfunction  

Event Description

Customer observed a discordant depressed atellica im 1600 br (br 27.29) result for a patient sample compared to initial testing of a different draw.The results were reported to the physician and were not questioned.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant elevated results.

Manufacturer Narrative

A us customer observed a discordant depressed atellica im 1600 br (br 27.29) result for a patient sample compared to initial testing of a different draw.Samples are run from aliquot tubes and retrieved from high-volume storage for repeat 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.".

Manufacturer Narrative

The initial mdr 1219913-2021-00479 was filed on (b)(6) 2021.A us customer reported additional elevated atellica im atellica im 1600 br (27.29) results for two patient samples compared to repeat testing.Atellica im br ca 27.29.Units of measure: u/ml.Sid , result , date: (b)(6), 30.86 , (b)(6) 2021; repeated , 46.36 , (b)(6) 2021; (b)(6), 33.92 , (b)(6) 2021; repeated , 35.83 , (b)(6) 2021; repeated , 40.03 , (b)(6) 2021; repeated , 54.18 , (b)(6) 2021; repeated , 31.49, (b)(6) 2021.Siemens is investigating.

Manufacturer Narrative

The initial mdr 1219913-2021-00479 was filed on november 4, 2021 and supplemental 1 mdr was filed on january 7, 2022.A us customer observed elevated, non reproducible atellica im 1600 br (27.29) lot: 257 results from patient samples.Samples were repeated on different atellica im analyzers and at times the testing lasted for more than two days post initial result.The atellica im br instructions for use (ifu) (11206410) indicates not to use samples that have been stored at room temperature for longer than 8 hours and to freeze samples at -20°c if the assay is not completed within 48 hours.The customer is aware of these limitations but they have validated the storage of br samples for longer duration.A review of data did not show a consistent cause for the difference in patient sample recovery between runs.In some instances the difference could be attributed to the br calibration, but not in every case.In some instances the qc recovery from a br primary readypack trended with the patient recovery off of the same pack indicating an issue with the pack, but not in every case.Instances of improper reagent handling and storage were noted at the customer's warehouse, during the time kit lot: 257 was stored there, and at the customer site, though not specifically with br packs.However, there is no direct evidence that the handling and storage of br reagents contributed to the issue.During the service at the customer site, solid phase particles were observed at the top of the ready packs which has the potential to impact sample recovery.Atellica im br kit lot: 257, expired 2021/11/10, so no internal studies were done with the lot, and the customer moved to atellica im br kit lot: 259.The cause(s) of the variability of patient sample recovery run to run seen by the customer when using atellica im br kit lot: 257 could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, normal assay performance, or reagent storage/handling.Based on the investigation, no product problem was identified.The customer is operational.No further action is required.In section h6, investigation finding and investigation conclusion codes were updated based on 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: 12754885
• MDR Text Key: 286022502
• Report Number: 1219913-2021-00479
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414598055
• UDI-Public: 00630414598055
• 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,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995478
• Device Lot Number: 257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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