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	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant ipth results is unknown.The patient samples are not available for further testing and evaluation.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 high advia centaur xp ipth result was obtained for samples from several patients during a comparison study.The comparison study was between reagent lot 368 on the advia centaur xp and an alternate method.The comparison was performed after the customer received complaints from doctors about shift up in results on patient samples.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 1219913-2017-00206 on (b)(6) 2017.09/26/2017 additional information: the customer's reference range is 14-72 pg/ml and the reference range for reference laboratory is 14.0-63 pg/ml.The quality control and calibrations are valid.The customer had rerun survey samples using the same regent lot and the results were all within acceptable limits.The customer typically runs edta samples.The reference range for edta as stated in the ifu is 13.8 to 85 pg/ml.The customer indicated they would revise their reference ranges to reflect edta samples.The patient samples are not avaialble for further testing and evaluation.Therefore, siemens is unable to determine the root cause of the discordant results.The customer repeated the correlation using 10 samples with another site.The slope observed was 1.03 between the two sites.The correlation is acceptable between the two sites.The cause for the discordant ipth results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the expected values section: "the reference range was established on the advia centaur system.Matched edta plasma and serum samples were obtained from 180 apparently healthy individuals whose calcium levels ranged from 8.0 to 10.3 mg/dl.The expected results (from 95% of the values) are: for plasma: 13.8-85.0 pg/ml (1.46-9.01 pmol/l), for serum: 12.4-76.8 pg/ml (1.31-8.14 pmol/l)." 10/04/2017 correction: (b)(6).

• 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: 6889853
• Report Number: 1219913-2017-00206
• Device Sequence Number: 116275
• Product Code: CEW
• UDI-Device Identifier: 00630414579153
• UDI-Public: 00630414579153
• Combination Product (Y/N): N
• 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): 10/04/2017

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: 03/24/2018
• Device Model Number: N/A
• Device Catalogue Number: 10492368
• Device Lot Number: 51223368
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1