MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP PROGESTERONE (PRGE) ASSAY; PROGESTERONE IMMUNOASSAY

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	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant, elevated advia centaur cp progesterone (prge) result was observed by the customer during a series of tests performed on one patient.A patient initially produced a result of <0.5 ng/ml, which triggered repeat testing according to local protocol.Upon repeat, the sample produced a result of 4.71 ng/ml.This higher result was considered discordant, as three additional tests produced results which agreed with the initial result.The lower measurement (0.50 ng/ml) was accepted as correct, and reported to the physician.There are no reports of adverse health consequences due to the discordant, high advia centaur cp progesterone (prge) result.
Additional Manufacturer Narrative
A united states customer reported observation of a discordant, elevated advia centaur cp progesterone result, and noted that no other issues were observed.Quality control (qc) testing results were within acceptable ranges at the time.Siemens is investigating.Within the limitations section of the product's instructions for use (ifu), the following is stated: "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.".
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2021-00497 on 2021-12-01.Additional information, 2021-12-06: siemens has concluded the investigation.A united states customer reported observation of a falsely elevated and discordant patient result when using the advia centaur cp progesterone (prge) assay.A result of 4.71 ng/ml was discordant relative to an initial result of 0.42 ng/ml and repeat results of 0.47, 0.46, and 0.50 ng/ml.The result of 4.71 ng/ml was considered discordant although patient medical information was not provided.Prge calibration and quality control results were acceptable at the time of the testing.The observed issue appears to be isolated to a single test replicate for one sample.Siemens is unable to definitively determine the cause of this discrepant result.Contributing factors such as sample handling and/or sample integrity cannot be ruled out.Quality control was in range, and no issues were noted with other patient samples, indicating that the instrument and reagents were performing acceptably.Repeat of the same sample yielded expected results.Based on the results of the investigation, return of the patient sample is not warranted.A potential product issue has not been identified, and the customer is operational.No additional action is required.Note: in section h6, the investigation findings and investigation conclusion codes have been updated based on the investigation results.

• Brand Name: ADVIA CENTAUR CP PROGESTERONE (PRGE) ASSAY
• Common Device Name: PROGESTERONE IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 12910418
• Report Number: 1219913-2021-00497
• Device Sequence Number: 14691374
• 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: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 12/10/2021

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: 12/15/2021
• Device Model Number: N/A
• Device Catalogue Number: 10310305
• Device Lot Number: 303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• 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