MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM PROGESTERONE (PRGE); RADIOIMMUNOASSAY, PROGESTERONE

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

The customer reported a discordant elevated progesterone patient results on an atellica im 1600 analyzer using reagent lot# 320.The elevated results were reported to the physician(s).The same samples were repeated on alternate atellica im 1600 analyzers; lower results were obtained.A corrected report was issued to the physician(s) for some of these samples.Progesterone (prge) controls also recovered high and out of insert range using the same reagent pack that produced the discordant results.Inspection of this progesterone (prge) reagent pack showed signs of clumped paramagnetic particles.The customer reported a similar issue with a second pack of prge reagent lot 320.Both packs were received in the same shipment.The shipment was investigated and found to have been delayed due to a weather event.Siemens customer service has replaced the reagent, and the customer is operational using prge lot 320 from a new shipment.Based on available information, the cause of the elevated results is consistent with an isolated shipping issue.The interpretation of results section of the atellica im progesterone instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".

Event Description

Discordant elevated progesterone patient results were obtained on an atellica im 1600 analyzer s/n: ih01255, lot#320.The elevated results were reported to the physician(s).The same samples were repeated on alternate atellica im 1600 analyzers; lower results were obtained.A corrected report was issued to the physician(s) for some of these samples.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated progesterone results.

• Brand Name: ATELLICA IM PROGESTERONE (PRGE)
• Type of Device: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18791164
• MDR Text Key: 336361489
• Report Number: 1219913-2024-00037
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 11206257
• Device Lot Number: 320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2023
• 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