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	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) and reported an observation of a discordant elevated advia centaur cp progesterone (prge) result on a patient sample versus repeat testing.Siemens is evaluating this issue.
Event or Problem Description
The customer reports an observation of a discordant elevated advia centaur cp progesterone (prge) result on a patient sample versus repeat testing.The discordant elevated result was not reported to the physician(s).The same sample was retested on the original advia centaur cp instrument and recovered lower results.The lower repeat results were considered correct, as the results correlated better with this patient's ultrasound findings.A result of 0.72 ng/ml was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant elevated prge result.
Additional Manufacturer Narrative
Mdr 1219913-2024-00299 was initially filed on 01-may-2024.Siemens has concluded the problem investigation.A united states (us) customer reported observation of an elevated advia centaur progesterone (prge) result which was discordant relative to repeat testing.Prge quality control (qc) results were within expected ranges.Service inspection revealed an issue with a fluid leak affecting cuvettes at the wash station.Multiple fluidics components (pumps, tubing, manifold) were replaced as part of a routine service response, and the leak was resolved.Following the service intervention, prge performance has been acceptable, and no further issues were reported.The instrument is performing according to specifications.The customer is operational, and the reported issue was resolved by service part replacement.In section h6, the codes for investigation findings, and investigation conclusions 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: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19220770
• Report Number: 1219913-2024-00299
• Device Sequence Number: 8194394
• Product Code: JLS
• UDI-Device Identifier: 00630414204147
• UDI-Public: 00630414204147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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: 09/13/2024
• Device Model Number: N/A
• Device Catalogue Number: 10310305
• Device Lot Number: 323
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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