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 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center to report an atellica im prolactin (prl) result within the non-pregnant female interval range for a patient that was considered discordant when compared to the higher result from an alternate method.The calibration was acceptable, and the quality control (qc) results were within the range.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens healthcare diagnostics is investigating.

Event Description

The customer obtained an atellica im prolactin (prl) result within the non-pregnant female interval range for a patient that was considered discordant when compared to the higher results from an alternate method.The patient is a non-pregnant female.The inital result was reported to the physician and questioned.The customer does not know which is the correct result.There are no known reports of patient intervention or adverse health consequences due to the discordant atellica im prl result.

Manufacturer Narrative

The initial mdr 1219913-2023-00015 was filed on january 17, 2023.An outside of the united states (ous) customer contacted the siemens customer care center to report an atellica im prolactin (prl) result within the non-pregnant female interval range for a patient that was considered discordant when compared to the higher result from an alternate method.March 24, 2023 additional information: siemens has investigated.The results for the sample from the alternate method assay testing were above the expected value for a non-pregnant patient.This is contrary to the patient history of a non-pregnant female and therefore should be considered the questionable results.There is no indication that the atellica im prolactin (prl) assay result produced was not correct based on the information about the patient provided.The analytical measuring range (amr) for the alternate method and the atellica im prolactin (prl) assay are different.The analytical measuring range (amr) for the alternate method is up to 470 ng/ml (0.0470-470 ng/ml) whereas the amr for the atellica im prl assay only goes up to 200 ng/ml (0.30-200.00 ng/ml) per the ifu 11200387_en rev.04, 2020-06.The results for the patient are not comparable with a one-to-one correlation due to the differences in the amr.The atellica im prl qc and calibration were verified by local team and deemed acceptable.The qc or calibration data was not provided to siemens for review.Based on the investigation, no product problem was identified.The customer is operational.

• Brand Name: ATELLICA IM PROLACTIN (PRL)
• Type of Device: PROLACTIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avemue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 7372808688
• MDR Report Key: 16184738
• MDR Text Key: 308738187
• Report Number: 1219913-2023-00015
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• 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: 03/24/2023
• 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