MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA); TOTAL PROSTATE SPECIFIC ANTIGEN 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	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) customer contacted the siemens customer care center (ccc) to report a discordant, low atellica im prostate-specific antigen (psa) result obtained on a patient sample.The instructions for use (ifu) states under the interpretation of results section the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instructions for use (ifu) states under the limitations section the following: "warning do not predict disease recurrence solely on serial psa values.Note, do not interpret levels of psa as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed prostate carcinoma frequently have levels of psa within the range observed in healthy individuals.Elevated levels of psa can be observed in patients with nonmalignant diseases.Measurements of psa should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation." siemens healthcare diagnostics is investigating.
Event or Problem Description
A discordant, low atellica im prostate-specific antigen (psa) result was obtained on a patient sample and questioned by the physician(s).The sample was repeated with the same instrument, resulting higher.The same sample was run on an alternative atellica im instrument, resulting higher.The initial result was reported and questioned.The repeated higher results were equivalent and aligned with the clinical history of the patient.The higher psa results were reported as the corrected result to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, low atellica im prostate-specific antigen (psa) result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2022-00060 on february 21, 2022.Correction: in b6 of the initial mdr, the date of the testing was presented as (b)(6) 2021.The correct date of testing is (b)(6) 2022.April 20, 2022, additional information: an outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report a low prostate specific antigen (psa) result on a patient sample when tested on atellica im 1600 with psa lot 317.The low result did not match patient's historical observations and was questioned.The same sample was repeated on the same day and system with lot 317 and an alternate atellica im and both results were higher as expected.Siemens healthcare diagnostics has reviewed the files provided for this escalation.The sample trace file around the patient sample aspiration showed signs of a poor aspiration and dispense of the initial psa result.No additional similar incidents have been reported from the customer.Based on the available information, atellica im psa kit lot 317 is performing as intended and a product issue was not identified.The customer is operational, and no further action is required.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA)
• Common Device Name: TOTAL PROSTATE SPECIFIC ANTIGEN 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: barry memishian ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13570461
• Report Number: 1219913-2022-00060
• Device Sequence Number: 11727551
• Product Code: MTF
• UDI-Device Identifier: 00630414599809
• UDI-Public: 00630414599809
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P950021
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 06/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995662
• Device Lot Number: 317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male