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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report discordant, a low advia centaur xp prolactin (prl) result on a male patient.No clinical information or historical prl results were provided for this patient.The sample recovered 8.15 ng/ml and 8.73 ng/ml when tested neat (undiluted) and 9.50 ng/ml when diluted 1:5.Further dilutions performed were 1:40, 1:200, 1:250 and 1:300.The prl values increased as the dilution factors increased but the relative light units (rlus) decreased.This is likely due to the sample being over-diluted and not a hook effect.There is the potential of reading below analytical sensitivity (on high dilution) and when multiplied by the dilution factor it could cause the prl dose to show an increase.The large dilution factors need to be used cautiously.Quality control and other patient samples are not affected.This issue only affected this patient sample.The sample is not available for further internal investigation and the patient is not scheduled to be redrawn.The customer continues to report controls and patients on the advia centaur prolactin assay.A potential product issue has not been identified.The instructions for use (ifu) states the following in the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the assay is performing within specification.No further evaluation of the device is required.Mdr 1219913-2020-00342 and mdr 1219913-2020-00445 were filed for the repeat results from the same patient on two different days.
Event or Problem Description
A false low advia centaur xp prolactin (prl) result was obtained on a patient and the reported result was questioned by the physician(s).The physician was expecting a higher prolactin result.The customer performed repeat neat (undiluted) testing of the sample, resulting low.Further sample dilutions were performed and the prl results increased as the dilution factor increased.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, low advia centaur prolactin (prl) result.

• Brand Name: ADVIA CENTAUR XP PROLACTIN (PRL)
• Common Device Name: PROLACTIN (PRL) IMMUNOASSAY,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 10722397
• Report Number: 1219913-2020-00341
• Device Sequence Number: 19696975
• Product Code: CFT
• UDI-Device Identifier: 00630414177267
• UDI-Public: 00630414177267
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K904714
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

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: 06/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 10309975
• Device Lot Number: 184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1