MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CA 19-9; IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

An outside the united states (ous) customer contacted the siemens customer care center (ccc) and reported a falsely depressed ca 19-9 (ca 19.9) result for a female patient on an atellica im 1600 analyzer.The sample was analyzed on an alternate atellica im instrument and the results were higher.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 ifu states in the limitations section: "warning do not use the atellica im ca 19-9 assay as a screening test or for diagnosis.Do not predict disease recurrence solely on levels of atellica im ca 19-9.Normal levels of atellica im ca 19-9 do not always preclude the presence of disease.Note: do not interpret serum levels of ca 19-9 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19-9 within the range observed in healthy individuals.Additionally, elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.Measurements of ca 19-9 should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.The concentration of ca 19-9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity.Ca 19-9 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.Therefore, it is important to use assay-specific values to evaluate quality control results." siemens is investigating.

Event Description

The customer reported a falsely depressed ca 19-9 result for a female patient's sample with the atellica im 1600 instrument that was considered discordant compared to other replicates of the same sample.The result was not questioned by the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, falsely depressed atellica im ca 19-9 result.

Manufacturer Narrative

The initial mdr, 1219913-2022-00006, was filed on 6 january 2022.14 april 2022 - additional information.An outside of the united states (ous) customer had a sample from a pancreatic cancer patient that recovered 870 ku/l with atellica im ca 19-9 kit lot 499 when measured on (b)(6) 2021 after yearly maintenance on atellica im irh008141948.This result is considered depressed to replicate testing that was performed using a different atellica im (irh008121948) where the sample recovered 1253 ku/l, 1335 ku/l, and 1242 ku/l.The result on atellica im irh008121948 (1253 ku/l) is considered to be correct.The customer was not able to provide a list of medications/supplements the patient was taking.Siemens reviewed the calibration and control data provided and lower qc recovery coincides with lower sample recovery.The customer's blood draw tube processing is in alignment with manufacturer's recommendations.The dilution recovery section of the atellica im ca 19-9 instructions for use (ifu) (10995285) indicates the diluted sample recoveries ranged from 76.8% - 129.5% and sample-dependent nonlinear dilutions can be observed.The customer decided to stop using ca 19-9 on atellica im irh008141948 and is only using atellica im irh008121948 for ca 19-9.The cause of the inconsistent diluted results seen by the customer with this sample when using ca 19-9 kit lot 499 on atellica im irh008141948 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.In section h6, the investigation findings and investigation conclusion codes were updated to reflect the investigation results.

• Brand Name: ATELLICA IM CA 19-9
• Type of Device: IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; e. walpole, MA 02032 ; 7818564812
• MDR Report Key: 13178982
• MDR Text Key: 286502732
• Report Number: 1219913-2022-00006
• Device Sequence Number: 1
• Product Code: NIG
• UDI-Device Identifier: 00630414598178
• UDI-Public: 00630414598178
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K031393
• 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
• Report Date: 04/29/2022

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: 06/18/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995490
• Device Lot Number: 499
• 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: 10/06/2021
• 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: 61 YR
• Patient Sex: Female