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

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2024

Event Type  malfunction  

Event Description

The customer reports observation of reproducibly elevated atellica im progesterone (prge) results for one patient which were discordant relative to clinical expectation and alternate-method testing.Discordant elevated progesterone results were observed for a 42-year-old female patient.An initial elevated prge result was obtained and questioned by the physician.A new sample was drawn and tested at another laboratory (using an alternate test method), and a much lower result was returned.This lower result was considered to be in agreement with other clinical indications.Later repeat testing reproduced the initial observations (reported separately).There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment in association with the observed discordance.

Manufacturer Narrative

A customer from outside the united states reported observation of reproducibly elevated atellica im progesterone (prge) results for one patient which were discordant relative to clinical expectation and alternate-method testing.The initial result, observed on (b)(6) 2024 is addressed in this report.The repeat observation of (b)(6) 2024 is reported separately.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.

Manufacturer Narrative

In section d4, the product lot number has been corrected from lot 320 to lot 322.The product expiration date has also been updated accordingly.

Manufacturer Narrative

Mdr 1219913-2024-00024 was initially submitted on 09-feb-2024.Siemens has concluded the investigation.A customer from outside the united states reported observation of reproducibly elevated atellica im progesterone (prge) results for one patient which were discordant relative to clinical expectation and alternate-method testing.Quality control (qc) results were within expected ranges, and no issues were reported for other patient samples.The customer investigated the potential presence of a endogenous sample interferent by treating the affected sample using a heterophilic blocking tube (hbt) and a non-specific binding tube (nsbt); lower results were observed.It is noted that the assay¿s instructions for use (ifu) contains the following statements, under limitations: ¿patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis.¿ ¿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 discordant observation may be associated with a sample-specific interferent.No product problem was identified.The customer is operational and no further action is required.Note: the codes for investigation findings and investigation conclusions in section h6 have been updated.

• Brand Name: ATELLICA IM PROGESTERONE (PRGE)
• Type of Device: 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: 18679534
• MDR Text Key: 335081452
• Report Number: 1219913-2024-00024
• Device Sequence Number: 1
• Product Code: JLS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K932955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10995660
• Device Lot Number: 322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female