MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR PROLACTIN (PRL); PROLCATIN IMMUNOASSAY

Model Number	10309976
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer tested patient samples across multiple days using advia centaur xp prolactin (prl) lot 203 and observed imprecision in the results.Initial results were reported to the physician(s) and were questioned.It is not known which results are correct.It is not known which results were accepted by the physician(s) as correct.There are no known reports of patient intervention or adverse health consequences due to the discordant prolactin results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report an observation of imprecision using advia centaur xp prolactin (prl) for patient samples tested across multiple days.Siemens field service engineer (fse) was dispatched to the site.The interpretation of results section of the atellica im folate (fol) instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.Mdr 1219913-2022-00380 was filed for testing on a different day.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2022-00381 initial report on 2022-11-02 and mdr 1219913-2022-00381 supplemental 1 report on 2022-12-08.Additional information - 2022-12-12 siemens concluded the investigation for an outside of the united states (ous) customer observation of imprecision on patient samples tested across multiple days using advia centaur xp prolactin (prl) lot 203.Siemens reviewed the instrument and event data, including actions performed by the siemens field service engineer (fse).The fse inspected the instrument and replaced the reagent probe 2 (rp2) diluter and reagent probe 3 (rp3).The instrument was then decontaminated which resolved the issue for the customer.There have been no further issues.Siemens concluded that the cause of the discordant result was due to the malfunction of the reagent probe 2 diluter as well as contamination of the system.The issue was resolved with replacement of the part as well as decontamination of the system as part of routine instrument troubleshooting.Based on the investigation, no product problem was identified.The system is operating as expected.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.Mdr 1219913-2022-00380 supplemental 2 was filed for for the same issue.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2022-00381 initial report on 2022-11-02.Additional information - 2022-11-14.Based on the service report that was provided, the following services occurred: rp2 diluter replaced (with rp3).Qc performed for 2 reagent lots (203 and 207) and precision after hardware change was acceptable (cv=2.7%).Patient precision after hardware change was ok (cv=2.3%).The customer will monitor performance with running patient sample in duplicate.No further issues have been reported after instrument decontamination and service.Siemens continues to investigate.Mdr 1219913-2022-00380 supplemental 1 was filed for the same issue.

• Brand Name: ADVIA CENTAUR PROLACTIN (PRL)
• Common Device Name: PROLCATIN 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: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 15719529
• Report Number: 1219913-2022-00381
• Device Sequence Number: 7251869
• Product Code: CFT
• UDI-Device Identifier: 00630414177274
• UDI-Public: 00630414177274
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2022

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: 11/20/2022
• Device Model Number: 10309976
• Device Catalogue Number: 10309976
• Device Lot Number: 203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/14/2022; 12/12/2022
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 12/08/2022; 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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