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 09/20/2021

Event Type  malfunction  

Event Description

Discordant, low atellica im ca 19-9 dilutions results were obtained on four patient samples and the reported results were questioned by the physician(s).The same samples were repeated on the same atellica im analyzer following new manual dilutions, entry of a dilution factor and using atellica im ca 19-9 diluent.The repeat dilution results were higher and reported to the physician(s) as the correct results.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, low atellica im ca 19-9 dilution results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report discordant, low atellica im ca 19-9 auto dilution results on four patient samples.Siemens has completed the investigation.A siemens product specialist (ps) was at the customer site to evaluate the issue.The siemens product specialist observed a strong smell from one of the manual dilutions bottles that customer had kept and the dilution solution looked turbid.The customer stated that the laboratory operators often keep used, not quite empty ch diluent (atellica chemistry) and ch cleaner (atellica chemistry) bottles at the table which may have led to the laboratory operator mistakenly using ch diluent for the manual dilution of the atellica im ca19-9.It is possible that atellica im ca19-9 diluent was not what was in the tube that the laboratory operator used for the initial (first) dilutions.For experimentation, the siemens product specialist with the customer, made a manual sample dilution with ch cleaner, resulting in an unclear diluted sample with a strong smell of chlorine.The potential cause for the discordant, low initial dilution results most likely can be attributed to the laboratory operator using an incorrect atellica im ca 19-9 dilution solution.The instructions for use (ifu) states the following 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 instructions for use (ifu) states the following 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.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 assay is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2021-00461 was 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 10591 5097
• MDR Report Key: 12610876
• MDR Text Key: 284024056
• Report Number: 1219913-2021-00460
• 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
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995489
• Device Lot Number: 494
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1