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

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

The customer reports observation of a discordant elevated result when running atellica im 1600 folate, lot 343.The initial result was reported to the physician(s), who did not question the result.The same sample was repeated on the same atellica im analyzer, and the result was lower.There are no allegations of patient harm, changes in treatment, or delay in diagnosis in association with the observed discordance.

Manufacturer Narrative

An outside the united states customer reports observation of a discordant elevated result when running atellica im 1600 folate, lot 343.The initial result was reported to the physician(s), who did not question the result.The same sample was repeated on the same atellica im analyzer, and the result was lower.There are no allegations of patient harm, changes in treatment, or delay in diagnosis in association with the observed discordance.The interpretation of results section of the atellica im folate instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens continues to investigate.

Manufacturer Narrative

Initial mdr 2432235-2023-00143 was filed on jun 08, 2023.Additional information ¿ july 07, 2023: an outside the united states customer reported the initial issue as a divergent repeat result of >-30% observed with a patient sample result tested on the atellica im instrument ih01085 lot 343 folate on (b)(6) 2023.Siemens evaluation included an assessment of reagent, instrument, and sample data.Reagent issues were ruled out based on a review of quality control (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 since the event, there were no more logs available to analyze.The customer reported that there have not been any issues with any divergent repeat results to date with patient samples tested on atellica im instrument ih01085 lot 343 folate, and agreed to notify siemens if the problem reoccurs.Review of atellica im fol lot 343 internal manufacturer release data shows the product is meeting all required specifications.Based on the available information, the cause of the discordant result is consistent with preanalytical variables.The return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM FOLATE ASSAY
• 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; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17085152
• MDR Text Key: 316754684
• Report Number: 2432235-2023-00143
• 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 Health Care Professional
• 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: 06/08/2023
• 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?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1