MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CA 15-3 (CA 15-3); CA 15-3 IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report a falsely low, atellica im ca 15-3 (ca 15-3) patient results.Siemens has completed the investigation.Based on the available information and a review of the complaint handling database, there were no other similar atellica ca15-3, reagent lot 188 complaints identified of other customers indicating this is a customer site specific issue.The repeated/corrected results were performed on atellica im system ih00497 and ih00582.Siemens has reviewed the customer calibrations and quality control (qc) during the time frame of the incident.The reagent readypack(s) in use at the time of the discordant ca 15-3 results had been run from a reagent lot calibration on a different reagent readypack saved from april 7, 2021.A review of the atellica im system error log noted reagent readypack mixing errors.The quality control (qc) results for one of the reagent readypacks was out of acceptable insert ranges.Reagent lot calibration is valid for reagent readypacks of the same reagent lot in use until the calibration interval expires, however qc out of range indicates a potentially compromised reagent readypack that was either not well mixed and/or exposed to light during shipping/handling/storage.The primary reagent readypack has since been replaced and quality control were repeated.A systemic product performance issue was not observed.The customer is operational.The instruction for use (ifu) states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instruction for use (ifu) states in the limitation warning and note section: "do not use the atellica im ca 15-3 assay as a screening test or for diagnosis.Normal levels of ca 15[- do not always preclude the presence of disease.Do not interpret levels of ca 15-3 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed breast carcinoma frequently have levels of ca 15-3 within the range observed in healthy individuals.Additionally, elevated levels of ca 15-3 can be observed in patients with nonmalignant diseases.Measurements of ca 15-3 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.
Event or Problem Description
Falsely low, atellica im ca 15-3 (ca 15-3) results were obtained on four patient samples and considered discordant compared to higher results observed when the same sample were re-tested on alternate atellica systems.The customer's quality control (qc) results were observed to be out of range at the time of the incident.The higher repeat results from the alternate atellica systems were reported as the corrected result to the physician(s).There are no known reports that treatment was altered or prescribed or adverse health consequences due to the discordant, atellica im ca 15-3 (ca 15-3) results.

• Brand Name: ATELLICA IM CA 15-3 (CA 15-3)
• Common Device Name: CA 15-3 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11826397
• Report Number: 1219913-2021-00245
• Device Sequence Number: 16409218
• Product Code: MOI
• UDI-Device Identifier: 00630414598123
• UDI-Public: 00630414598123
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K012357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995486
• Device Lot Number: 188
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1