MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA); TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 12/29/2023

Event Type  malfunction  

Event Description

The customer obtained a discordant depressed prostate-specific antigen (psa) result on a patient sample on atellica im 1600 analyzer.The initial result was not reported to the physician(s).The sample was retested on the same atellica im 1600 analyzer, and the result was similar to the initial result.This sample was retested on two different alternate testing platforms and the results were higher.The higher result tested on the second alternate method was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this discordant depressed prostate-specific antigen (psa) results.

Manufacturer Narrative

A customer from outside the united states obtained a discordant depressed prostate-specific antigen (psa) result on a patient sample on atellica im 1600 analyzer.The initial result was not reported to the physician(s).The sample was retested on the same atellica im 1600 analyzer, and the result was similar to the initial result.This sample was retested on two different alternate testing platforms and the results were higher.The higher result tested on the second alternate method was reported to the physician(s).The interpretation of results section of the atellica im prostate-specific antigen (psa) instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is evaluating.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2024-00009 on 17-jan-2024.Additional information on 29-jan-2024: a customer from outside the united states obtained a discordant depressed prostate-specific antigen (psa) result on a patient sample on atellica im 1600 analyzer.The initial result was not reported to the physician(s).The sample was retested on the same atellica im 1600 analyzer, and the result was similar to the initial result.This sample was retested on two different alternate testing platforms and the results were higher.The higher result tested on the second alternate method was reported to the physician(s).Siemens reviewed customer's calibration data and was valid and comparable with release and quality control (qc) recovered within ranges.As per atellica im prostate-specific antigen (psa) instructions for use (ifu) 10995416_en rev.05, 2022-10 limitations section: "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." "prostate cancer patients under treatment with anti-androgens and lhrh agonists may exhibit markedly reduced levels of psa.Also, men treated for benign prostatic hyperplasia with inhibitors of 5¿ reductase (finasteride) may demonstrate a significant reduction in psa levels compared to values prior to treatment.Care should be taken when interpreting values from these individuals." additionally, in the warning section it states: "the concentration of total psa in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay for total psa used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of total psa is changed, the laboratory must perform additional testing to confirm baseline values." this seems to be an isolated event and patient specific and customer is operational and reporting other psa samples.

• Brand Name: ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA)
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18530720
• MDR Text Key: 333132861
• Report Number: 1219913-2024-00009
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: 00630414599816
• UDI-Public: 00630414599816
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P950021-S016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10995663
• Device Lot Number: 331
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male