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 10/08/2021

Event Type  malfunction  

Event Description

A customer observed a low atellica im prolactin (prl) result on 2 different samples taken from the same patient.The depressed results are considered discordant compared to alternate method testing results and patient clinical history.The initial result was reported to the physician who questioned the result.A corrected report has not been issued.There are no known reports of patient intervention or adverse health consequences due to the discordant prolactin results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted siemens healthcare diagnostics regarding observations of discordant low results from a patient.Siemens is investigating.Calibrations and quality control (qc) results were acceptable.Siemens has requested additional information.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 ifu states: "pregnancy, lactation, and the administration of oral contraceptives can increase prolactin concentrations" "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." mdr 1219913-2021-00476 was filed for the discordant result obtained on (b)(6) 2021.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2021-00477 initial report on 2021-11-04.Correction - based on information received on 2021-11-16.Section b5 - both initial and repeat results were provided to the physician.Section b6 - the alternate test method results were performed by the patient in another laboratory, with a different sample.The historical results have always been carried out with the same alternate test method.Additional information - 2021-11-16: section d2 and h4 have been updated with lot number information (lot 197; expiration date 2022-05-06, manufacture date 2021-05-06).The patient is not pregnant and is postmenopausal.Dosage of estradiol in the second sample draw was performed: 46.9 pg/ml siemens continues to investigate.Mdr 1219913-2021-00476 was filed for the same complaint.

Manufacturer Narrative

Siemens healthcare diagnostics filed initial report on 2021-11-04 and supplemental 1 report on 2021-12-09.Additional information - 2021-12-21: siemens has completed the investigation for a customer observation of low discordant patient results from one patient tested on the atellica im prolactin (prl) assay versus results of an alternate test method.The 49 year old female patient, with a history of prolactinemia, results 8.6 ng/ml on the atellica im prl assay.The same sample tested with an alternate method results significantly higher at 50.53 ng/ml.A new sample from this patient shows a similar result pattern between the atellica im and the alternate method prolactin assays.The patient's historical results (tested with the alternate method) showed similar high results.This patient is taking a medication meant to lower prolactin levels.Quality control and other patient samples are not affected.This issue only affected samples from this particular patient.Sample is not available for further internal investigation by siemens.It is not known if dilutions were attempted with this patient sample at the customer site.While the exact root cause of the lower results on the atellica im prl assay cannot be determined, siemens cannot rule out a non-specific interferent.Immunoassays are subject to a number of interferences including those caused by endogenous antibodies.Interference can occur because of heterophile antibodies, anti-animal antibodies and auto antibodies.Patients exposed to animals or animal serum products can be prone to this interference and anomalous values may be observed.The interfering antibodies can give rise to a falsely high or less commonly a falsely low result.The erroneous result is recognized as being inconsistent with the patient's clinical picture.The limitations section of the atellica im prolactin instruction for use 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." based on the available information, a potential product performance issue has not been identified.The customer is operational.No further investigation in required.In section h6, the investigation type, findings and conclusion codes were updated based on the investigation results.Mdr 1219913-2021-00476 supplemental 2 report was filed for the same issue.

• 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: 12753598
• MDR Text Key: 284813751
• Report Number: 1219913-2021-00477
• Device Sequence Number: 1
• Product Code: CFT
• UDI-Device Identifier: 00630414599731
• UDI-Public: 00630414599731
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995655
• Device Lot Number: 197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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: 49 YR
• Patient Sex: Female