MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR XPT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens technical support laboratory performed in-house testing with afp kit lots 04191 and 041199.Calibrations and quality controls were within acceptable ranges.The kit lots are performing within manufacturing specifications.Siemens is investigating the issue.Mdrs 2432235-2017-00531_s4 , mdr 2432235-2017-00599_s2, mdr 2432235-2017-00625_s2, and mdr 2432235-2017-00660_s1 were filed for the same issue.

Event Description

A discordant, falsely elevated alpha-fetoprotein (afp) result was obtained on one patient sample on an advia centaur xpt instrument.The sample was repeated twice on the same instrument, resulting lower.It is unknown if the initial or repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated afp result.

Manufacturer Narrative

The initial mdr 2432235-2018-00156 was filed on 16-apr-2018.Additional information (11-may-2018): siemens headquarters support center and regional support center specialists visited the customer site and did not identify a system issue.Siemens is investigating the issue.Mdrs 2432235-2017-00531_s5, mdr 2432235-2017-00599_s3, mdr 2432235-2017-00625_s3, and mdr 2432235-2017-00660_s2 were filed for the same issue.

Manufacturer Narrative

The initial mdr 2432235-2018-00156 was filed on 16-apr-2018.The first supplemental mdr 2432235-2018-00156_s1 was filed on 05-jun-2018.Additional information (07-may-2018): while the siemens regional support center (rsc) and headquarters support center (hsc) specialists were at the customer site, they performed complete system check.The vacuum speed was verified and recalibrated to a lower value, reagent probe 1 was replaced and calibrated as it was bent, reagent probe 1 calibration at incubation ring dispense port was verified and adjusted, sample digital diluter assembly was proactively replaced to eliminate a potential sample delivery issue, and valves were proactively checked and replaced to ensure optimal wash around functionality of the aspirate probes.Incorrect aspirate probe calibrations were observed and were set back to default positions.A defect on aspirate probe 3 tubing was observed due to rubbing on the tubing management clip.The tubing was replaced with a new one.The aspirate probes and probe wash guides were proactively replaced.A precision testing was performed on three hundred replicates of low calibrator for alpha-fetoprotein (afp) and the coefficient of variation was 9.5%.A hanging water drop on wash separation manifold dispense ports 1 and 3 during baseline afp run was observed.The water valves and wash separation manifold were replaced to address the water drops.Pinch valve tubing was replaced proactively to ensure optimal wash aspiration functionality.The reagent probe 1 diluter assembly and associated water valve were replaced proactively to ensure optimal reagent delivery.The water filter and water degasser were also replaced proactively.A precision testing was performed on sixty replicates of low calibrator for afp and the coefficient of variation was 16%.Background counts, dry, wetwater, and wetwash1 tests were performed.It was found that the dry values with relative light units (rlus) were in the single digits indicative of potential contamination issue.A decontamination procedure was performed for acid and base lines with bleach followed by hydrogen peroxide.Background counts and other three tests were performed and the rlus improved.The extensive system checks performed on this instrument did not reveal a conclusive definitive failure of the instruments mechanical functionality.A precision testing was performed on hundred replicates of low calibrator for afp and the coefficient of variation was 11%.The imprecision for the last precision study was potentially due to the effects of the decontamination still being worked out of the system.Upon the recommendation of siemens, the customer replaced the ionizer assembly and acid and base pumps, checked the acid and base pumps to see if there was a gap at the end of the piston, and replaced the reagent probe heater coil.Siemens investigated the issue and determined that since the decontamination procedure, the customer has not received imprecision on afp patient samples.The review of the precision data of the low end samples performed by the customer showed it was within expected range.The potential cause of the imprecise afp results on the patient samples was due to the contamination issue.The instrument is performing within manufacturing specifications.No further evaluation of device is required.Method, result and conclusion codes have been updated in section h6.Mdrs 2432235-2017-00531_s6, mdr 2432235-2017-00599_s4, mdr 2432235-2017-00625_s4, mdr 2432235-2018-00660_s3, 2432235-2018-00307, 2432235-2018-00308, 2432235-2018-00309, 2432235-2018-00310, 2432235-2018-00311, and 2432235-2018-00312 were filed for the same issue.

• Brand Name: ADVIA CENTAUR XPT
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7433696
• MDR Text Key: 106025276
• Report Number: 2432235-2018-00156
• Device Sequence Number: 0
• Product Code: LOJ
• Combination Product (y/n): N
• PMA/PMN Number: K141999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XPT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1