MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ENHANCED ESTRADIOL (EE2); RADIOIMMUNOASSAY, ESTRADIOL

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	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer reported a difference in serum patient sample results on a patient with atellica im enhanced estradiol (ee2) lot 105 depending on which ancillary reagent pack is used.Initial result using one ancillary pack was higher than a retest result obtained with a different ancillary pack.The lower retest result was reported as correct.There are no allegations of patient or user intervention or adverse health consequences due to the event.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.
Event or Problem Description
The customer reported a difference in serum patient sample results on a patient with atellica im enhanced estradiol (ee2) lot 105 depending on which ancillary reagent pack is used.Initial result using one ancillary pack was higher than a retest result obtained with a different ancillary pack.The lower retest result was reported as correct.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens investigated an outside the united states (ous) customer report of a difference in results with atellica im enhanced estradiol (ee2) reagent lot 105 depending on which ancillary pack was used.Initial results obtained with pack id#: p12710510056319 / a12773385031606 were higher than retest results obtained with pack id#: p12710510056312 / a12773385032025.For one patient sample, the initial result was more than 30% higher than the retest result.The lower retest result was reported as correct.The customer orders the atellica im ee2 500 test kit configuration which comes with 5 primary reagent packs (readypacks), each containing reagent to perform 100 tests, and 4 ancillary reagent packs (anc pack) containing 9.4 ml of ancillary reagent.The readypacks may deplete prior to the anc packs based on the pack sizes and testing.The ee2 anc packs are not lot locked (i.E., not paired with a specific primary reagent lot/kit).Siemens evaluated the event and identified the following: the initial and retest results were generated using the same calibration (id#: 1131 date of calibrations on (b)(6) 2025 07:25:39 gmt).Quality control (qc) run before and after the patient samples resulted within range.Analyzer trace files showed no issues with aspiration and/or dispense of ee2 reagents or samples.Analyzer autocheck data showed that wash probe valve vacuum pressure was reading near the low end of the acceptable range.Siemens service applications specialist inspected the analyzer and performed vacuum troubleshooting.Following the service, 3 different patient samples were tested using 3 readypacks and 3 anc packs from lot: 105.The results compared well between the different readypack and anc pack combinations.Internal reagent release data showed that atellica im ee2 lot: 105 met all manufacturer specifications.No evidence of a systemic reagent or instrument issue was identified.Based on the manufacturer¿s evaluation into this reported complaint, the exact cause of the discordant results cannot be determined but is consistent with normal wear and tear of analyzer parts.A trend is not identified showing a systemic issue.The customer is operational, and the reported issue was resolved by optimizing the vacuum pressure which is a standard troubleshooting and service action.Report of a difference in results with atellica im enhanced estradiol (ee2) reagent lot: 127105 depending on which ancillary pack was used.Initial results obtained with pack id#: p12710510056319 / a12773385031606 were higher than retest results obtained with pack id#: p12710510056312 / a12773385032025.For one patient sample, the initial result was more than 30% higher than the retest result.The lower retest result was reported as correct.The customer orders the atellica im ee2 500 test kit configuration which comes with 5 primary reagent packs (readypacks), each containing reagent to perform 100 tests, and 4 ancillary reagent packs (anc pack) containing 9.4 ml of ancillary reagent.The readypacks may deplete prior to the anc packs based on the pack sizes and testing.The ee2 anc packs are not lot locked (i.E., not paired with a specific primary reagent lot/kit).Siemens evaluated the event and identified the following: the initial and retest results were generated using the same calibration (id#: 1131 date of calibrations on (b)(6) 2025 07:25:39 gmt).Quality control (qc) run before and after the patient samples resulted within range.Analyzer trace files showed no issues with aspiration and/or dispense of ee2 reagents or samples.Analyzer autocheck data showed that wash probe valve vacuum pressure was reading near the low end of the acceptable range.Siemens service applications specialist inspected the analyzer and performed vacuum troubleshooting.Following the service, 3 different patient samples were tested using 3 readypacks and 3 anc packs from lot: 105.The results compared well between the different readypack and anc pack combinations.Internal reagent release data showed that atellica im ee2 lot: 105 met all manufacturer specifications.No evidence of a systemic reagent or instrument issue was identified.Based on the manufacturer¿s evaluation into this reported complaint, the exact cause of the discordant results cannot be determined but is consistent with normal wear and tear of analyzer parts.A trend is not identified showing a systemic issue.The customer is operational, and the reported issue was resolved by optimizing the vacuum pressure which is a standard troubleshooting and service action.Siemens filed initial mdr 1219913-2025-00154 on 01-aug-2025.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM ENHANCED ESTRADIOL (EE2)
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 22689153
• Report Number: 1219913-2025-00154
• Device Sequence Number: 18370688
• Product Code: CHP
• UDI-Device Identifier: 00630414598857
• UDI-Public: (01)00630414598857(10)01126105(17)251204
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 12/12/2025

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 Model Number: N/A
• Device Catalogue Number: 10995561
• Device Lot Number: 01126105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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