MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA); PROSTATE-SPECIFIC ANTIGEN IMMUNOASSAY

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer reported observation of reproducible depressed atellica im prostate-specific antigen (psa) results for one patient which disagreed with alternate-method testing.No issues were identified with quality control (qc) results or calibration for either assay.The medical director requested re-draw of the patient.The assay's instructions for use (ifu) states the following, under interpretation of results: "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 investigating.

Event Description

The customer reports observation of reproducible depressed atellica im prostate-specific antigen (psa) results for one patient which disagreed with an alternate method during a method-comparison study.Psa lot 331 was in use at the time.The customer has recently begun using the atellica im psa assay, and has been comparing patient results from the atellica im platform against results generated by their other established method.For one patient, atellica im psa produced much lower results than the alternate method.An initial low atellica im psa result was obtained, and similar results were produced when the sample was repeat-tested.The initial low result was reported to the physician, and questioned.The higher result produced by the alternate method was considered correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.

Manufacturer Narrative

Mdr 1219913-2023-00303 was initially submitted on 2023-11-28.A united states customer reported observation of reproducible depressed atellica im prostate-specific antigen (psa) results for one patient which disagreed with alternate-method testing.Assay calibration data were valid and comparable to kit performance at product release.It was noted that the customer¿s quality control (qc) results trended low relative to defined ranges.The discordant psa result was reproducible when repeat-tested using the initial instrument and an additional atellica im analyzer, indicating that the depressed result was not indicative of a system-specific issue.Sufficient sample material was not available for additional testing by siemens, and the patient has not been re-drawn.No information regarding the patients medications and/or supplements is available.The patient has a history of metastatic prostate adenocarcinoma and is being treated for it.Historical psa results for this patient (from either method used) indicate a potential recurrence of prostate cancer.Per the assay¿s instructions for use (ifu) "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." the ifu provides the following warning: ¿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." no product problem was identified.The customer is operational and no further action is required.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA)
• Type of Device: PROSTATE-SPECIFIC ANTIGEN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 18215639
• MDR Text Key: 329106704
• Report Number: 1219913-2023-00303
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: 00630414599809
• UDI-Public: 00630414599809
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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: 10995662
• Device Lot Number: 331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• 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 Sex: Male