MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM FOLATE (FOL); FOLATE ASSAY

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The outside the us customer reports observation of an elevated patient sample result when using atellica im 1300 folate (fol) assay.After repeating with dilution, the results were significantly lower than the initial result.It is unknown which result is correct.Quality control (qc) levels were back in range after calibration.The interpretation of results section of the atellica im folate (fol) 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 healthcare diagnostics is investigating.
Event or Problem Description
The customer reports observation of an elevated patient sample result when using atellica im 1300 folate (fol) assay.After repeating with dilution, the results were significantly lower than the initial result.It is unknown which result is correct.There are no known reports of patient intervention or adverse health consequences due to the discordant folate results.
Additional Manufacturer Narrative
Initial mdr 1219913-2022-00412 was filed on nov 23, 2022 reporting an outside the us customer reports observation of an elevated patient sample result when using atellica im 1300 folate (fol) assay.After repeating with dilution, the results were significantly lower than the initial result.Additional information - dec 07, 2022.Section d8 - was this device serviced by a third party? updated to no.The customer confirmed the sample type: serum.The initial result was not reported to the physician(s).The repeated (diluted) results were considered as correct by the physician(s).Siemens continues to investigate.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2022-00412 on nov 23, 2022 siemens filed the mdr 1219913-2022-00412 supplemental 1 on dec 19, 2022.Additional information on jan 27, 2023: an outside the united states customer reported observation of elevated patient sample result higher than the measuring interval (>54,36 nmol/l) and after dilution, the result is in range and significantly lower than the initial result.The customer used the reagent lot 339.The sample was a serum sample: the customer uses sarstedt tube, specifically serum gel.The sample was tested directly from the primary tube as well as for repeat/dilution testing.The issue was reproducible with repeat testing with multiple calibrations, multiple ancillary dtt preparations.Siemens determined that the instrument is diluting sample appropriately based on 27 other patient samples diluting as expected.The lab did not determine if the patient was on any medications that could interfere with folserum.There is no evidence of sample integrity errors.The sample had h/i/l calculated to be 0.Siemens concludes that pre-analytical variables can affect the quality of the sample, and deviation from recommended best practices can impact results.While there is insufficient information to determine the cause of the discrepant result, siemens cannot rule out pre-analytical variables or sample specific issues as contributing factors.No product issue has been identified.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM FOLATE (FOL)
• Common Device Name: FOLATE ASSAY
• 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: 15852262
• Report Number: 1219913-2022-00412
• Device Sequence Number: 15032263
• Product Code: CGN
• UDI-Device Identifier: 00630414598963
• UDI-Public: 00630414598963
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K172201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995572
• Device Lot Number: 339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 12/07/2022; 01/27/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/19/2022; 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown