MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP PROLACTIN (PRL); PROLACTIN (LACTOGEN) TEST SYSTEM

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the advia centaur xp prolactin (prl) discordant results is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
Discordant low advia centaur xp prolactin (prl) results were obtained on a patient sample.The results were discordant with the high results from the support laboratory using an alternate method.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant prolactin (prl) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00257 on december 19, 2017.February 15, 2018 additional information: the patient samples were not available for further investigation and testing.The advia centaur xp and the alternate method results cannot be directly compared given differences in antibody specificity across the different vendor's assays.Siemens is unable to rule out differences in antibody selection causing cross reactivity or possible medications/treatments causing an interference as the cause of this discordant results.Quality control and other patient samples are not affected.This issue only affected this patient sample.The cause for the advia centaur xp prolactin (prl) discordant results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP PROLACTIN (PRL)
• Common Device Name: PROLACTIN (LACTOGEN) TEST SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7128097
• Report Number: 1219913-2017-00257
• Device Sequence Number: 1880060
• Product Code: CFT
• UDI-Device Identifier: 00630414177274
• UDI-Public: 00630414177274
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K904714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 10309976
• Device Lot Number: 031163
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR