MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA CENTAUR 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	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
One (1) falsely elevated progesterone (prge) patient sample result was obtained on an advia centaur xp instrument.The initial falsely elevated result was not reported to the physician.The same sample was retested twice on the original instrument and lower results were obtained.A new sample was redrawn from the same patient and tested on the same instrument, obtained a lower result.The retested result obtained from the initial sample was considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated progesterone (prge) result.
Additional Manufacturer Narrative
An outside united states (ous) customer reported one (1) falsely elevated progesterone (prge) patient sample result obtained on an advia centaur xp instrument.The advia centaur progesterone (prge) instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is evaluating the event.
Additional Manufacturer Narrative
The initial mdr 1219913-2023-00309 was filed on 16-nov-2023.Additional information - 06-dec-2023: siemens concluded the investigation for an outside of the united states (ous) customer observation of a falsely elevated non-reproducible result for one female sample on the advia centaur progesterone (prge) assay with reagent lot 317.The lower repeat results were believed to be correct.Siemens evaluated the instrument data and the information provided by the customer.The sample was not recentrifuged before being repeated.Visual inspection of the sample did not show any signs of fibrin.The quality controls (qc) were within ranges and no instrument errors were found with the system during time of this event.Service was not dispatched since the issue was isolated to just one sample.Based on the available information, the cause of the discordant result is consistent with a sample integrity issue.A product problem has not been identified.The customer is operational.I in section g1, a typographical error was corrected.The initial mdr 1219913-2023-00309 filed on 16-nov-2023, incorrectly listed ¿lukos¿ as the contact office name and was corrected to ¿loukos¿ in this report.

• Brand Name: ADVIA CENTAUR 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: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18246584
• Report Number: 1219913-2023-00309
• Device Sequence Number: 7116268
• Product Code: JLS
• UDI-Device Identifier: 00630414454641
• UDI-Public: 00630414454641
• 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): 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): 12/28/2023

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: 02/24/2024
• Device Model Number: N/A
• Device Catalogue Number: 10315522
• Device Lot Number: 317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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 Age: 40 YR
• Patient Sex: Female