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	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant ipth results is unknown.Siemens healthcare diagnostics is investigating.The limitations section of the instructions for use states: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.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.".
Event or Problem Description
Discordant advia centaur ipth results were obtained for samples from the same patient.The physician questioned the elevated results.The physician was expecting normal results since the patient had normal scans and has not had surgery.The customer performed a dilution.The dilution indicated a potential interfering substance.Patient treatment was not prescribed or altered.There was no report of adverse health consequences as a result of these discordant ipth results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00142 on june 14, 2017.08/10/2017 additional information: the physician was expecting a normal ipth result.The reference range for the ipth assay is 14-72 pg/ml.All results were abnormal based on the reference range.Calcium values were normal.No clinical information provided.Siemens is unable to determine the cause of the discordant ipth results.However, a sample specific issue can not be ruled out.The cause for the discordant ipth result is unknown.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the expected results section: "the reference range was established on the acs:180® system.Edta plasma samples were obtained from 142 apparently healthy individuals whose calcium levels ranged from 8.0 to 10.3 mg/dl.Ninety-five percent of the intact pth values for these individuals fell in the range of 14 to 72 pg/ml (1.48 to 7.63 pmol/l) with an overall range of 11.1 to 79.5 pg/ml (1.18 to 8.43 pmol/l).These results were confirmed for the advia centaur intact pth assay.Refer to method comparison.As with all in vitro diagnostic assays, each laboratory should determine its own reference range(s) for the diagnostic evaluation of patient results.".

• 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: 6641074
• Report Number: 1219913-2017-00142
• Device Sequence Number: 13656908
• Product Code: CEW
• UDI-Device Identifier: 00630414579160
• UDI-Public: 00630414579160
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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: 03/24/2017
• Device Model Number: N/A
• Device Catalogue Number: 10492368
• Device Lot Number: 31310368
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1