MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM FOLATE (FOL); ACID, FOLIC, RADIOIMMUNOASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 03/25/2023

Event Type  malfunction  

Event Description

The customer observed an elevated result for the atellica im folate (fol) assay which was considered discordant with the lower repeat result for a patient sample.The initial result was reported and was not questioned by the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated result.

Manufacturer Narrative

An outside united states (ous) customer contacted a siemens customer care center to report an elevated result for the atellica im folate (fol) assay which was considered discordant with the lower repeat result for ap tient sample.The calibration and quality control (qc) were acceptable on the day of the event.The ifu states in the interpretation of results section: "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.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2023-00142 on june 07, 2023.An outside united states (ous) customer contacted a siemens customer care center to report an elevated result for the atellica im folate (fol) assay which was considered discordant with the lower repeat result for a patient sample.July 07, 2023 additional information: siemens investigation included an assessment of reagent, instrument, and sample data.Reagent issues were ruled out based on review of qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.Siemens requested instrument logs.Given the length of time of the data, there were no more logs available to analyze.Siemens performed a review of the atellica im folate (fol) lot 343 internal manufacturer release data and it showed the product is meeting all required specifications.Based on the available information, the cause of the discordant result is consistent with preanalytical variables.Return of the patient sample for further investigation is not warranted because discordant result was not reproducible.No further evaluation of the device is required.

• Brand Name: ATELLICA IM FOLATE (FOL)
• Type of Device: ACID, FOLIC, RADIOIMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 511 benedict ave.; tarrytown, NY 10591 ; 7372808688
• MDR Report Key: 17083108
• MDR Text Key: 316795556
• Report Number: 2432235-2023-00142
• Device Sequence Number: 1
• Product Code: CGN
• UDI-Device Identifier: 00630414598970
• UDI-Public: 00630414598970
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K172201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995573
• Device Lot Number: 343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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