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	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the false high advia centaur xp intact parathyroid hormone (ipth) results on the original sample draw is unknown, however pre-analytical/sample specific issue or an unidentified interference cannot be ruled out.The customer's quality control (qc) and calibration were valid, and there were no other discordant samples observed on this day with other assays.There is no sample available for testing by siemens due to the sample storage at the customer site which has rendered the specimen unsuitable for testing.The instruction for use (ifu) under the limitation section states the following: "it is also extremely important to ensure that patient samples have been handled and stored correctly.Incorrect handling of samples will result in a loss of intact pth." 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.Mdr 1219913-2018-00161 was filed for a falsely elevated repeat result on the same patient.
Event or Problem Description
A false high advia centaur xp intact parathyroid hormone (ipth) result was obtained on a patient sample and the result was questioned by the physician.The patient was redrawn the following day and the result was lower.The customer performed repeat ipth testing of the original sample, the redrawn sample, and the results were similar to what was originally obtained.The lower ipth result from the redrawn sample was considered to be consistent with the patient's clinical picture.Patient treatment was not altered or prescribed or adverse health consequences due to the discordant advia centaur xp ipth results.Mdr 1219913-2018-00161 was filed for a falsely elevated repeat result on the same patient.

• 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: 7542237
• Report Number: 1219913-2018-00160
• Device Sequence Number: 16612264
• Product Code: CEW
• UDI-Device Identifier: 00630414579153
• UDI-Public: 00630414579153
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/24/2018

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: 12/12/2018
• Device Model Number: N/A
• Device Catalogue Number: 10492368
• Device Lot Number: 056372
• 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: 05/01/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR