MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TNI ULTRA; TROPONIN IMMUNOASSAY

Catalog Number	10317709
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens investigation is complete.Siemens reviewed the complaint information provided to determine probable root cause.Instrument maintenance was performed on (b)(6) 2019 with reagent kit lot 22935163.The calibration directly following maintenance was invalid.Relative light units (rlus) were low for both low and high calibrator potential that two low calibrators were processed instead of a low and high calibrator set.Two successful calibrations were subsequently performed on (b)(6) 2019 (approximately 4am and 9am).Both were marked successful however the rlus on the second calibration at 9am were about 1/2 that of the 4am calibration rlus and not typical for the recent tni ultra calibrations on that system with the same kit lot.The low and high calibrator rlus were decreased by similar amount so calibration evaluation ranges were within range, however this calibration had a high slope of 2.88 compared to the prior calibration slope of 1.3.Quality control (qc) was within the customer ranges on (b)(6) 2019 prior to running patient samples with a result of 0.1101 ng/ml.Qc manufacturer insert range for the qc material is 0.084 - 0.125 ng/ml.Siemens suggested the customer review their range for this control as their upper end of range is higher than qc manufacturer insert allowance.In addition, qc level 99563 while in customer range, has no advia centaur xp insert range for tni ultra.Qc was high out of the customer range the next morning (b)(6) 2019 after patient samples were run.This alerted the customer of the issue and caused them to repeat the patient samples.The repeated results were all lower than the initial results.As part of investigation, customer began use of a new reagent pack; qc was out of range.After recalibration, repeat qc results were within the acceptable limits.The elevated samples from (b)(6) 2019 and were more elevated as the day went on.This would indicate a condition that became worse over time, i.E., if acid/base/wash bottles were swapped during maintenance and the system ran off of the reservoir with mixed reagents for a period of time or if there was residual cleaning solution in the water bottle or system after maintenance.This could also indicate an improperly mixed ready pack that went into solution after continuous rocking.While root cause cannot be determined, siemens cannot rule out improper/incomplete system maintenance or an issue with readypack handling as a factor contributing to the falsely elevated tni ultra results.This is a site specific issue that has been corrected.There is no confirmed product performance issue.No further evaluation of the device is required.The instructions for use states in the taking corrective action section, "if the quality control results do not fall within the expected values or within the laboratory's established values, do not report results." the instructions for use states in the interpretation of results section, "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
A customer observed multiple falsely elevated advia centaur xp tni ultra results on (b)(6) 2019 on one instrument with one reagent readypack.Quality control (qc) was within the customer range on (b)(6) 2019 prior to running patient samples.Qc was high out of the customer range the next morning (b)(6) 2019 after patient samples were run.This alerted the customer of the issue and the patient samples were repeated.The repeated results were all lower than the initial results.Corrected reports were issued.Patient treatment was not prescribed or altered and there was no report of adverse health consequences due to the initial elevated tni ultra results.

• Brand Name: ADVIA CENTAUR XP TNI ULTRA
• Common Device Name: TROPONIN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9513082
• Report Number: 1219913-2019-00283
• Device Sequence Number: 13973272
• Product Code: MMI
• UDI-Device Identifier: 00630414516226
• UDI-Public: 00630414516226
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K053020
• 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): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2020
• Device Catalogue Number: 10317709
• Device Lot Number: 22935163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1