MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM PROLACTIN (PRL); PROLACTIN IMMUNOASSAY

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 01/25/2023

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contact siemens to report an observation of a discordant atellica im prolactin (prl) patient sample result.The interpretation of results section of the 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." the limitations section of the instructions for use (ifu) states: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis." siemens is investigating the issue.

Event Description

The customer obtained an atellica im prolactin (prl) patient sample result that was considered discordant when compared to the result from an alternate method.The initial result was repoerted to the physician and questioined.The customer reported all results in a corrected report.There are no known reports of patient intervention or adverse health consequences due to the discordant prl result.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2023-00025 initial report on 2023-02-17.Additional information on 2023-02-22: siemens identified that the analytical measuring range (amr) for the alternate test method (up to 470 ng/ml) is different from the siemens test method amr (up to 200 ng/ml).The patient sample result in should not be compared in a direct correlation between methods.Correction - 2023-02-28: siemens confirmed the contact name and phone number is different than was listed in section e1 of the mdr 1219913-2023-00025 initial report on 2023-02-17.Section e1 of this report was updated with the correct information.Additional information on 2023-03-20: siemens concluded investigation for an outside the united states (ous) customer observation of a discordant (depressed) atellica im prolactin (prl) patient result when compared to an alternate method.Quality control (qc) and calibration data was not provided in the complaint, but qc and calibration was verified by the local siemens team and deemed acceptable.It should be noted that the analytical measuring range (amr) for the alternate method and siemens atellica im prl assay are different.The amr for the alternate method is 0.047 - 470 ng/ml, where the siemens atellica im method is 0.30 - 200.00 ng/ml, as listed in the assay instructions for use (ifu) 11200387_en rev.04, 2020-06.The patient sample result should not be compared in a direct correlation due to the differences in the amr.The sample result given for the alternate method was above the expected range for the method for non-pregnant females (2.8 ng/ml - 29.2 ng/ml).This is contrary to the patient history (non-pregnant female) and therefore should be considered questionable.There is no indication that the siemens result produced was not correct based on the patient information provided, as it was within the expected range for non-pregnant females (4.79 ng/ml - 23.3 ng/ml).Based on the investigation, no product problem was identified.The customer is operational.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM PROLACTIN (PRL)
• Type of Device: PROLACTIN 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: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 16401096
• MDR Text Key: 310162249
• Report Number: 1219913-2023-00025
• Device Sequence Number: 1
• Product Code: CFT
• UDI-Device Identifier: 00630414599748
• UDI-Public: 00630414599748
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995656
• Device Lot Number: 209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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: Female