MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY; IPTH IMMUNOASSAY,

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	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the false low advia centaur xp intact parathyroid hormone (ipth) result on a dilution sample is unknown, and appears to be sample specific due to a possible unknown interferent.The customer's quality control results were acceptable at the time of event.The customer had a different patient sample that was high for ipth (>1900 pg/ml), and the auto dilution (1:5) result (3406.5 ng/ml) was acceptable.The customer performed a manual dilution (1:5) of this different patient sample for additional troubleshooting, and the result comparison of the auto dilution (3406.5 ng/ml), and manual dilution (2709.5 pg/ml) was considered to be acceptable (20.46% difference).There is no known interference with the medications the patient is taking, and there is no patient sample available for further investigation.The customer has declined a customer service visit by siemens.The instruction for use (ifu) under the interpretation of results section states the following: 'results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the instruction for use (ifu) under the limitation section states the following: "interpretation of intact pth values should always take into account serum calcium results and the interrelationship between these two 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." the instrument is performing within specification.No further evaluation of the device is required.
Event or Problem Description
A false low advia centaur xp intact parathyroid hormone (ipth) result was obtained on a dilution sample, and considered discordant compared to a high neat result.The customer performed repeat ipth testing, and the neat result was high compared to a lower dilution result.The same sample was re-centrifuged, repeat ipth testing performed, and the results were similar.Another sample aliquot from the same patient was tested, and the ipth results were similar.The high ipth result was reported to the physician, and considered to be the correct result.The reported result was not questioned by the physician.Patient treatment was not altered or prescribed or adverse health consequences due to the discordant advia centaur xp ipth result.

• Brand Name: ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY
• Common Device Name: IPTH IMMUNOASSAY,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 6870217
• Report Number: 1219913-2017-00194
• Device Sequence Number: 1354311
• Product Code: CEW
• UDI-Device Identifier: 00630414579153
• UDI-Public: 00630414579153
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K133601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2017

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: 01/17/2018
• Device Model Number: N/A
• Device Catalogue Number: 10492368
• Device Lot Number: 056366
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1