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	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer received the mcms (master curve material) to run.The mcms were run and all the levels were within range.Mcm lot# 72254, tested with reagent lot 368.Mcm1: observed: 0.6, target: 0, ranges: < 7.5, mcm2: observed: 26.8, target: 28.1, ranges: 18.3 - 37.9, mcm3: observed: 49.9, target: 50.6, ranges: 32.9 - 68.3, mcm4: observed: 138.1, target: 132, ranges: 92.4 ¿ 172, mcm5: observed: 347, target: 345, ranges: 242 ¿ 449, mcm6: observed: 868 target: 866, ranges: 606 ¿ 1126, mcm7: observed: >1900, target: 2493, ranges: >1900.The customer ran the quality control with reagent lot 368 and all the levels within ranges.Qc lot 60211: observed: 8.33, ranges: 6.22 - 15.22, qc lot 60212: observed: 93.88, ranges: 77.35 - 121.03, qc lot 63213: observed: 341.4, ranges: 290.4 -386.4.Siemens reviewed in house data to release reagent lot 368.The reagent lot 368 recovered slightly lower than reagent lot 366.All the samples were within manufacturer's acceptable ranges.The customer quality control was within range.The master curve material results provided were all within range.Siemens does not confirm a product nonconformance issue.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 specimen collection and handling section: "correct handling of patient samples is critical to ensure the integrity of the intact pth molecule.Intact pth has been demonstrated to be labile and is susceptible to fragmentation.This instability depends on both time and temperature.Patient sample stability is outlined in the following table: temperature: room temperature, edta plasma stability: 8 hours, serum stability: 4 hours; 4 degree c, 72 hours, 48 hours; -70 degree c, 8 months, not tested".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
A false low advia centaur xp ipth result was obtained for a patient sample during a lot to lot correlation.The correlation was between reagent lot 366 and 368.Lot 368 was reading lower than lot 366.The patient result from lot 368 was not reported.Patient treatment was not prescribed or altered.There was no report of adverse health consequences as a result of these discordant ipth results.

• 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: 6762154
• Report Number: 1219913-2017-00172
• Device Sequence Number: 1570542
• Product Code: CEW
• UDI-Device Identifier: 00630414579153
• UDI-Public: 00630414579153
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 08/02/2017

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: 056368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1