MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM PROGESTERONE (PRGE); RADIOIMMUNOASSAY, PROGESTERONE

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	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated atellica im progesterone patient results which were discordant relative to repeat testing when using lot 322.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 evaluating the event.
Event or Problem Description
The customer reported an observation of discordant elevated patient results with the atellica im progesterone (prge) lot#322.These samples were tested while quality control (qc) results were outside established ranges.The elevated results were not reported to the physician(s).The samples were repeated on the same atellica im analyzer once qc results were within established ranges; lower patient results were obtained.Repeat testing results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the event.Sample data: please refer to ¿2024-00056832-1_prge_patients sample data_calculations¿ attached for patient sample data and calculations for complaint (b)(4).Please refer to ¿2024-00056832-2_prge_patients sample data_calculations¿ attached for patient sample data and calculations for complaint (b)(4).Note: complaint (b)(4) addresses the discordant observations of (b)(6) 2024.Complaint (b)(4) addresses the discordant observations of (b)(6) 2024.
Additional Manufacturer Narrative
Mdr 1219913-2024-00373 was initially filed on 24-jul-2024.Additional information 25-jul-2024: siemens has concluded the investigation.The customer obtained discordant results on the atellica im progesterone (prge) assay with reagent lot 322.On june 27, 2024, biorad immunoassay plus qc lot 85340 levels 1 and 3 recovered high and outside published insert ranges.The customer tried repeating with new qc aliquots, but results remained high.Next, they repeated qc with a new prge lot 322 primary reagent pack and the results recovered within range.The reagent pack used for qc and patient testing that was removed from the atellica im analyzer and was inspected and found to contain clumped (aggregated/precipitated) paramagnetic particles (pmp).Per siemens labeling, reagent packs must be inspected for clumping prior to use, if clumping is observed resuspension is required and clumped reagent packs cannot be used for sample processing.The customer repeated the patient samples on the same atellica im analyzer once qc results were within range using the new reagent pack.They identified 21 discordant results; lower patient results were obtained.The repeat results were considered correct and were reported to the physician(s).This reagent lot was received by the customer in multiple shipments.All on-hand boxes of prge lot 322 reagent packs were inspected; none of the inspected reagent packs showed evidence of clumping.Based on available information, the cause of the falsely elevated qc and patient results is consistent with the isolated clumped reagent.The customer has been operational since they replaced the reagent pack that exhibited clumped pmp.No systemic product issue was identified.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM PROGESTERONE (PRGE)
• Common Device Name: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19821060
• Report Number: 1219913-2024-00373
• Device Sequence Number: 8671241
• Product Code: JLS
• UDI-Device Identifier: 00630414599779
• UDI-Public: 00630414599779
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K932955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 08/13/2024

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: 09/12/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995659
• Device Lot Number: 96057322
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• 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