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	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the false high advia centaur xp intact parathyroid hormone (ipth) result is unknown.The customer has performed additional studies (study results not provided) and is reporting patient results with the new ipth reagent lot (056368).Siemens is investigating.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.".
Event or Problem Description
A false high advia centaur xp intact parathyroid hormone (ipth) result was obtained, and considered discordant compared to a lower advia centaur system ipth result from a sister hospital.The customer initially observed a high bias for level 3 quality control (qc) even though qc was within the laboratory's established range.There was no qc improvement with a new ipth reagent lot (056368), and the false high ipth result was observed when performing a patient result comparison with the sister hospital.Per the laboratory director, patient results greater than 73 pg/ml will be held for verification testing.Patient treatment was not altered or prescribed or adverse health consequences due to the discordant advia centaur xp ipth result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00178 on 08/10/2017 for a false high advia centaur xp intact parathyroid hormone (ipth) patient result.08/11/17 - additional information: the customer was provided master curve material for troubleshooting, and the results were within established ranges.A correlation study was performed with new reagents of the same lot, and the results acceptable (customer data not provided).The customer has declined any further assistance.The cause for the false high advia centaur xp intact parathyroid hormone (ipth) patient result compared to a lower advia centaur system ipth result from a sister hospital in unknown.No conclusion can be drawn.Customer master curve material results: level: mcm1, target: 0, range: < 7.5, result: 1.Mcm2, 28.1, 18.3 - 37.9, 29.Mcm3, 50.6, 32.9 - 68.3, 53.Mcm4, 132.0, 92.4 - 172.0, 135.Mcm5, 345.0, 242.0 - 449.0, 353.Mcm6, 866.0, 606.0 - 1126.0, 893.Mcm7, >1900, > 1900, 2493.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 specifications.No further evaluation of the device is required.

• 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: 6786236
• Report Number: 1219913-2017-00178
• Device Sequence Number: 1565819
• Product Code: CEW
• UDI-Device Identifier: 00630414579153
• UDI-Public: 00630414579153
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 08/28/2017

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: 01/17/2018
• Device Model Number: N/A
• Device Catalogue Number: 10492368
• Device Lot Number: 056366
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1