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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states (ous) customer called the siemens customer care center (ccc) to report a discordant, elevated atellica im psa result from a patient that was considered discordant compared to the clinical history of the patient.The patient had previously had surgery for prostate cancer.The limitations section of the instructions for use states: "warning do not predict disease recurrence solely on serial psa values." "the atellica im psa assay is intended to be used as an aid in the detection of prostate cancer and as an aid in the management (monitoring) of prostate cancer patients, in accordance with current clinical practice guidelines.These guidelines define biochemical recurrence of prostate cancer as a detectable or rising psa value post-radical prostatectomy that is >/= 0.20 ng/ml (¿g/l) with a second confirmatory level of >/= 0.20 ng/ml (¿g/l), thus use of psa values < 0.20 ng/ml (¿g/l) is not recommended to identify patients at risk of biochemical recurrence of prostate cancer." siemens is investigating.
Event or Problem Description
The customer contacted the siemens customer care center (ccc) to report a discordant, elevated atellica im prostate-specific antigen (psa) result from a patient that was considered discordant compared to the clinical history of the patient.The patient had previously had surgery for prostate cancer.The elevated atellica im psa result was reported to the physician.A positron emission tomography (pet) scan was performed on the patient.There are no reports of adverse health consequences due to the elevated atellica im psa result.
Additional Manufacturer Narrative
Initial mdr was filed on 19-apr-2022.Additional information: 19-may- 2022.An outside of the united states (ous) customer contacted the customer care center (ccc) and reported an initial, falsely elevated prostate-specific antigen (psa) result for a patient using the atellica im 1600.The falsely elevated result of 0.34 ng/ml was observed in january 2022 for a 74-year-old prostatectomy patient using reagent lot 315.The patient had a low result when tested on the same system and psa lot 315 three months prior.In addition, a new sample drawn two months later was tested on their alternate atellica system with psa lot 317 and that result was also low.There was no sample available to be send in for further evaluation and, the sample was not repeated, and it was not tested with heterophilic blocking tubes (hbt).Siemens reviewed the customer's calibration data for lot 315 and the recovery was comparable with release data and the qc recovery was acceptable.The issue seems to be a sample specific issue and sample handling cannot be ruled out.Based on the available information atellica im psa lot 315 is performing as intended and a product performance issue has not been identified.The customer is operational.No further action is needed.In section h6, investigation finding, and investigation conclusion codes were updated based on additional information.

• 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; e. walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; e. walpole, MA 02032 ; 7818564812
• MDR Report Key: 14141065
• Report Number: 1219913-2022-00114
• Device Sequence Number: 20406157
• Product Code: MTF
• UDI-Device Identifier: 00630414599809
• UDI-Public: 00630414599809
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/14/2022

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995662
• Device Lot Number: 315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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: 74 YR
• Patient Sex: Male