MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ATELLICA IM PROGESTERONE (PRGE); PROGESTERONE 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	04/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a discordant elevated atellica im progesterone result for one infertile female patient sample, using lot 314.The sample was repeated on the same atellica im, which gave a result similar to the initial result.The same sample was repeated on an alternate method, which gave lower results compared to the atellica im results.The lower result from these repeats was reported to the physician(s).For troubleshooting purpose only, the sample was also repeated on a advia centaur xp instrument, which gave results similar to the atellica im results.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated progesterone results.
Additional Manufacturer Narrative
An outside the united states customer observed a discordant elevated atellica im progesterone result for one infertile female patient sample, using lot 314.The sample was repeated on the same atellica im, which gave a result similar to the initial result.The same sample was repeated on an alternate method, which gave lower results compared to the atellica im results.The lower result from these repeats was reported to the physician(s).For troubleshooting purpose only, the sample was also repeated on a advia centaur xp instrument, which gave results similar to the atellica im results.The qc results were within the normal ranges when this sample was tested.The interpretation of results section of the atellica im progesterone instructions for use (ifu) 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.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00082 on apr 11, 2023.Additional information apr 14, 2023 and may 04, 2023: an outside the united states customer observed a discordant elevated atellica im progesterone result for one infertile female patient sample, using lot 314.The sample was repeated on the same atellica im, which gave a result similar to the initial result.The same sample was repeated on an alternate method, which gave lower results compared to the atellica im results.The lower result from these repeats was reported to the physician(s).For troubleshooting purpose only, the sample was also repeated on a advia centaur xp instrument, which gave results similar to the atellica im results.Reagent issues were ruled out based on review of quality control (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.No information regarding the medication and/or supplementation taken by this patient could be provided.No historical atellica im progesterone results from this patient were available.The remaining volume was insufficient for an internal investigation.The atellica im progesterone assay instructions for use (ifu) have the following limitations statement: "with the advent of new steroid-based medications (analogues) with similar chemical structures to progesterone, there is the possibility of cross-reactivity and falsely elevated results.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.If the progesterone results are inconsistent with clinical evidence, additional testing is suggested to confirm the result." based on the available information, the cause of the discordant result is consistent with a sample specific interferent.A potential product performance issue has not been identified.The customer is operational.

• Brand Name: ATELLICA IM PROGESTERONE (PRGE)
• Common Device Name: PROGESTERONE ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 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: 16714388
• Report Number: 1219913-2023-00082
• Device Sequence Number: 15272501
• Product Code: JLS
• UDI-Device Identifier: 00630414599779
• UDI-Public: 00630414599779
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K932955
• 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): 05/08/2023

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: 06/07/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995659
• Device Lot Number: 314
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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 Age: 30 YR
• Patient Sex: Female