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 Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

The customer has reported three discordant, low atellica im ca 19-9 results for a cancer patient in treatment.Siemens is investigating.The instructions for use (ifu) states the following, under limitations: "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." "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis." mdr 1219913-2020-00210 and mdr 1219913-2020-00211 were filed for the same patient tested on different dates using different systems and a different lot.

Event Description

A customer observed three low atellica im ca 19-9 results for a patient that were considered discordant compared to positive results from an alternate method and the patient's clinical condition.There are no reports of patient intervention or adverse health consequences due to the discordant low atellica im ca 19-9 results.

Manufacturer Narrative

Mdr 1219913-2020-00209 was filed on 13-aug-2020 to report a low atellica im ca 19-9 result which was considered discordant relative to positive results from an alternate method and the patient's clinical condition.Additional information october 1, 2020: siemens has concluded the incident investigation.Calibration and control data were reviewed, and no evidence of a problem was found.The patient is known to have pancreatic cancer; the customer was not able to provide a list of medications/supplements the patient was taking.There is not enough sample to be sent to siemens for evaluation.The expected values section of the atellica im ca 19-9 instructions for use (ifu) states that 75% of samples from patients with a pancreatic malignant disease recovered >37 iu/ml, indicating that 25% of samples from patients with a pancreatic malignant disease recovered <37 iu/ml.As stated in the limitations section of the atellica im ca 19-9 ifu: - "this device is not indicated for screening or the early detection of pancreatic cancer or as a diagnostic tool to confirm the presence or absence of malignant pancreatic disease.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." - "do not interpret serum levels of ca 19 9 as absolute evidence of the presence or the absence of malignant disease." - "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." the cause of the discrepant results seen for samples from this one patient when using atellica im ca 19-9 could not be determined but pre-analytical factors or a sample issue cannot be ruled out.The observations fall within the range of normal assay performance.No product problem was identified.In section h6, the investigation findings and investigation conclusion codes were updated to reflect the additional information.Mdr 1219913-2020-00210 supplemental 1 and mdr 1219913-2020-00211 supplemental 1 were filed for the same event.

• 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
• MDR Report Key: 10401025
• MDR Text Key: 234881683
• Report Number: 1219913-2020-00209
• Device Sequence Number: 1
• Product Code: NIG
• UDI-Device Identifier: 00630414598161
• UDI-Public: 00630414598161
• Combination Product (y/n): N
• PMA/PMN Number: K031393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995489
• Device Lot Number: 462
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1