MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP 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	06/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant ipth result is unknown.Siemens service went on site and cleaned the luminometer and verified reagent probe alignments.They also performed qc with all results in range.The system was returned to operation.At a follow up visit, a total service call was performed.An issue was found with the rinse blocks and they were replaced.Service performed qc with all results in range.Service also performed a precision run of 5 replicates with all expected results.The system was returned to operation.No conclusions can be drawn.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." the intended use section of the instructions for use states: "for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (ipth) in edta plasma or serum using the advia centaur cp system.This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypothyroidism.".
Event or Problem Description
Customer observed a lower than expected advia centaur cp intact parathyroid hormone (ipth) result.Upon repeat testing, the result was higher.This was an intraoperative ipth test result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur cp ipth result.
Additional Manufacturer Narrative
Siemens submitted mdr 1219913-2017-00152 on july 18, 2017 reporting a lower than expected advia centaur cp intact parathyroid hormone (ipth) result.That was higher upon repeat testing.August 15, 2017 - additional information: after the second field service visit, no additional discordant results have been observed.The discordant result could have been caused by rinse block failure.Since the discordant result could not be reproduced at the time of the troubleshooting this is considered an isolated event that cannot be confirmed.No further investigation is required.

• Brand Name: ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (IPTH) ASSAY
• Common Device Name: IPTH IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• MDR Report Key: 6720604
• Report Number: 1219913-2017-00152
• Device Sequence Number: 1444861
• Product Code: CEW
• UDI-Device Identifier: 00630414579153
• UDI-Public: 00630414579153
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

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: 02/13/2018
• Device Model Number: N/A
• Device Catalogue Number: 10492368
• Device Lot Number: 22367367
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1