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

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 04/14/2021

Event Type  malfunction  

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 different atellica im systems and reagent readypacks.The initial and repeat results were above the instructions for use 99th percentile cutoff of 32.4 u/ml.Siemens has reviewed the customer calibrations and quality control (qc) during the time frame of the incident.The reagent readypack ((b)(4)) in use at the time of the discordant ca 15-3 results later exhibited qc and calibration failures.The potential cause of the discordant results may be a compromised reagent readypack that was using a prior acceptable reagent lot calibration.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, assay calibration and quality control were repeated with acceptable results.There have been no issues observed with the use of a new reagent readypack.A 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 Description

Falsely low, atellica im ca 15-3 (ca 15-3) results were obtained on three patient samples and considered discordant compared to higher results observed when the same sample were re-tested on alternate atellica systems with different reagent readypacks from the same reagent lot number.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)
• Type of Device: CA 15-3 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: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 11826394
• MDR Text Key: 252430143
• Report Number: 1219913-2021-00249
• Device Sequence Number: 1
• Product Code: MOI
• UDI-Device Identifier: 00630414598130
• UDI-Public: 00630414598130
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K012357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• 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