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	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an elevated advia centaur progesterone (prge) result which was discordant relative to repeat testing while using lot 321.An initial elevated result (above assay measuring range) was obtained for a female patient.This elevated result was not reported to the physician.The sample was re-tested after manual dilution (1:2) and produced a much lower result.The same sample was repeat-tested neat (undiluted) and a similar low result was obtained.This lower result was consistent with clinical expectation, accepted as correct, and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of elevated advia centaur progesterone (prge) result which was discordant relative to repeat testing while using lot 321.Quality control (qc) recovered within customer established ranges.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.
Additional Manufacturer Narrative
Mdr 1219913-2024-00344 was initially filed on 07-jun-2024.Additional information (21-jun-2024): siemens healthcare diagnostics has concluded the investigation of the event.Siemens evaluated the instrument data and the information provided by the customer.Reagent and instrument issues were ruled out based on qc recovery within acceptable ranges and no issues were reported with other patient samples.The system reagent probe 2 volume check error occurred around the time when the discordant result was generated.The issue was resolved by routine troubleshooting.A product problem has not been identified.Customer is operational; no further actions are required.In section h6, the investigation findings and investigation conclusions codes were updated.

• 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.; registration #1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 19493334
• Report Number: 1219913-2024-00344
• Device Sequence Number: 12539327
• Product Code: JLS
• UDI-Device Identifier: 00630414454641
• UDI-Public: 00630414454641
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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): 07/11/2024

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: 06/09/2024
• Device Model Number: N/A
• Device Catalogue Number: 10315522
• Device Lot Number: 321
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 23 YR
• Patient Sex: Female