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	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was not enough sample to perform serial dilution to rule out hamma or heterophilic interference.The remaining sample was sent to a referenece laboratory for ipth determination.The result was not provided.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.Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis.".
Event or Problem Description
Discordant advia centaur xp ipth results were obtained for a patient sample.The patient sample had a result greater than 1900.The sample was diluted (1:5) and the results were low.Patient treatment was not prescribed or altered.There was no report of adverse health consequences as a result of these discordant ipth result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00183 on august 24, 2017.08/25/2017 additional information: the physician was expecting a normal ipth result.The only information provided was that the clinical chemistry tests for the patient were normal and no intra-operative ipth was ever ordered.The patient sample was sent to a reference laboratory for ipth testing and the sendout result was reported as the final result.The customer could not find the send out report to provide the test method or result obtained to siemens.The patient sample is not available for in-house testing.Therefore, the cause of the discordant ipth result can not be determined.Siemens cannot rule out a potential unidentified interference in the patient sample.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: 6818896
• Report Number: 1219913-2017-00183
• Device Sequence Number: 137119
• Product Code: CEW
• UDI-Device Identifier: 00630414579160
• UDI-Public: 00630414579160
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/18/2017

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: 10492369
• Device Lot Number: 38520368
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1