MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOTICS, INC ADVIA CENTAUR XP INTACT PTH; RADIOIMMUNOASSAY PARATHYROID HORMONE

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the customer diluted out the sample and observed a non-linear value, there appears to be a non- specific interference.Immunoassays are subject to a number of interferences.No further sample is available at this time.The cause for the discordant ipth result is unknown.The instrument is performing within specifications.No further evaluation of the device is required.The interpretation of results of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the instructions for use states: "interpretation of intact pth values should always take into account serum calcium results and the interrelationship between these 2 elements in various disorders involving pth and calcium.It is recommended that the intact pth results should always be interpreted with caution and with consideration of the overall clinical manifestations even when used in conjunction with calcium values.".
Event or Problem Description
Customer observed an advia centaur xp intact pth result of 484 pg/ml that was elevated compared to an alternate method and the clinical picture.There are no reports that treatment was altered or prescribed on adverse health consequences due to the elevated advia centaur xp intact pth result.

• Brand Name: ADVIA CENTAUR XP INTACT PTH
• Common Device Name: RADIOIMMUNOASSAY PARATHYROID HORMONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOTICS, INC; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8201039
• Report Number: 1219913-2018-00304
• Device Sequence Number: 1557210
• Product Code: CEW
• UDI-Device Identifier: 00630414592336
• UDI-Public: 00630414592336
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K163658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 08/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 10699154
• Device Lot Number: 62210017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1