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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states customer observed elevated quality controls (qc) results and a patient sample result that was elevated compared to repeat testing, when using the folate (fol) assay on the atellica im 1600.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 continues to investigate.
Event or Problem Description
The customer observed elevated quality controls (qc) results and a patient sample result that was elevated compared to repeat testing, when using the folate (fol) assay on the atellica im 1600.The initial result was reported to the physician(s), who did not question the result.There are no known reports of patient intervention or adverse health consequences due to the discordant folate result.
Additional Manufacturer Narrative
Initial mdr 1219913-2022-00356 was filed on october 14, 2022 reporting an outside the united states customer observed elevated quality controls (qc) results and a patient sample result that was elevated compared to repeat testing, when using the folate (fol) assay on the atellica im 1600.Additional information - october 19, 2022: the customer stated that the samples are automatically stored in the cold storage unit.Siemens continues to investigate.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2022-00356 on oct 14, 2022.Siemens filed the mdr 1219913-2022-00356 supplemental 1 on nov 15, 2022.Dec 12, 2022, additional information: an outside the united states customer reported observation of falsely elevated quality controls (qc) and a patient sample result when using atellica im 1600 folate (fol) assay, lot 335.The customer noted qc level 3 (immuplus3) 3 standard deviations (sd) failure and qc level 1 (immuplus1) 2 sd failure at the same time 3 patients were ran.The 3 patients were then retested on 3 different analyzers.The customer then recalibrated the instrument which had the failed qc and controls were in after the recalibration.Based on siemen's review of the dec records, the elevated qc and patient result were directly correlated to the calibration on sep 28, 2022.Calibration on oct 5, 2022 with the same reagent pack resulted in qc within expected 2 sd ranges.No product performance issue has been identified.The system 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: 15606944
• Report Number: 1219913-2022-00356
• Device Sequence Number: 2236490
• Product Code: CGN
• UDI-Device Identifier: 00630414598970
• UDI-Public: 00630414598970
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 12/20/2022

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: 11/22/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995573
• Device Lot Number: 335
• 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: 10/05/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 12/12/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/15/2022; 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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