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	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the issue was the low qc (quality control) for ipth lot 369.However, the value for the qc was in range.One patient sample had a discordant low result.The issue was resolved after the customer recalibrated the ipth assay.The qc returned close to the target and the patient result was higher upon repeat.The higher result was reported.The customer continues to process samples for ipth with reagent lot 369.The instrument is performing within specifications.No further evaluation of the device is required.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
The customer observed a zero result for a patient sample on the advia centaur xp intact parathyroid hormone (ipth) assay after calibration.The customer stated that the quality control was in range after the calibration.The zero result was not reported.The customer recalibrated on (b)(6) 2017 with a fresh set of calibrators.The quality control was repeated and the values were in range.The patient sample was repeated and the result was higher.The higher result was reported.Patient treatment was not prescribed or altered.There was no report of adverse health consequences as a result of the discordant 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: 6976083
• Report Number: 1219913-2017-00219
• Device Sequence Number: 1549520
• Product Code: CEW
• UDI-Device Identifier: 00630414579160
• UDI-Public: 00630414579160
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 10/25/2017

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: 06/14/2017
• Device Model Number: N/A
• Device Catalogue Number: 10492369
• Device Lot Number: 77912369
• 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: 10/10/2017
• Initial Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1