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 09/02/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens personnel was dispatched to the customer site.The siemens personnel ran dry, wetwash1 and wetwater as decontamination tests, which passed.The probe alignments were acceptable and the reagents were mixed properly.A precision testing was performed for afp assay.A siemens headquarters support center (hsc) specialist reviewed the afp precision data and determined that the system is performing as expected.The cause of the imprecise ap results on one patient sample is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

Imprecise alpha-fetoprotein (afp) results were obtained on one patient sample upon initial and repeat testing on an advia centaur xpt instrument.It is unknown which result is considered correct and reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the imprecise afp results.

Manufacturer Narrative

The initial mdr 2432235-2017-00531 was filed on september 27, 2017.Additional information (10/03/2017): upon further review of information, it was determined that the afp imprecision still persisted.The siemens personnel stated that the wash manifold was checked and wash cycle was visually observed, which was functioning properly.However, relative light units for wetwater test were intermittently high.The aspirate probes and aspirate probe pinch valves were replaced.During the cleaning procedure, it was noted that the aspirate probe 3 cuvette was overflowing.The cause of the imprecise afp results on one patient sample is unknown.Siemens is investigating the issue.Result and conclusion code(s) has been updated.Additional information (10/06/2017): additional information regarding afp value being reported and the reporting units have been received.

Event Description

The repeat alpha-fetoprotein (afp) result of 7.5 ng/ml was reported to the physician(s).

Manufacturer Narrative

The initial mdr 2432235-2017-00531 was filed on september 27, 2017.The first supplemental mdr 2432235-2017-00531_s1 was filed on october 27, 2017.Additional information (10/17/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided and stated that the background and precision data were acceptable.A siemens customer service engineer (cse) revisited the customer site and replaced the acid pump, degasser, and reagent 1 diluter.The cuvette overflow occurred during alpha-fetoprotein (afp) sample processing.There was a residual film around the wash 1 dispense port.This could result in wicking from droplets accumulating on the port.During a revisit to the customer site, the cse ran dry test, wet water test and wash 1 test and the relative light units were below 150.The cse determined that there were solution stain marks underneath the wash manifold near acid probe.Additionally, during the daily cleaning procedure, the aspirate probe 3 was overflowing.However, during the sample processing, no overflow was observed.The cause of the imprecise afp results on one patient sample is unknown.Siemens is investigating the issue.Corrected information (11/06/2017): the initial mdr states that the "date of event" is (b)(6) 2017.The correct event date is (b)(6) 2017.Date of event has been updated with this information.Mdr 2432235-2017-00599 was filed for the event occurred on (b)(6) 2017.

Manufacturer Narrative

The initial mdr was filed on 27-sep-2017.The first supplemental mdr was filed on 27-oct-2017.The second supplemental mdr was filed on 07-nov-2017.Additional information (28-nov-2017): a siemens customer service engineer (cse) revisited the customer site.The cse checked the system levelling and aspirate probe 1 home position to verify that it is at the same level as the other aspirate probes.The aspirate probe home position could not be verified as the aspirate home position tool available at that time was for advia centaur xp instrument.The cse checked and adjusted the vacuum setting using the vacuum tool, checked and replaced the re-suspend valves to verify that they are not causing droplets at the dispense ports and replaced the wash manifold and luminometer.Siemens is still investigating the issue.Mdr 2432235-2017-00599_s1 was filed for the event occurred on (b)(6) 2017.Mdr 2432235-2017-00625_s1 was filed for the event occurred on (b)(6) 2017.Mdr 2432235-2017-00660 was filed for the event occurred on (b)(6) 2017.

Manufacturer Narrative

The initial mdr 2432235-2017-00531 was filed on 27-sep-2017.The first supplemental mdr 2432235-2017-00531_s1 was filed on 27-oct-2017.The second supplemental mdr 2432235-2017-00531_s2 was filed on 07-nov-2017.The third supplemental mdr 2432235-2017-00531_s3 was filed on 21-dec-2017.Additional information (05-apr-2018): siemens technical support laboratory performed in-house testing with alpha fetoprotein 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 2432235-2017-00599_s2, mdr 2432235-2017-00625_s2, mdr 2432235-2017-00660_s1, and mdr 2432235-2018-00156 were filed for the same issue.

Manufacturer Narrative

The initial mdr 2432235-2017-00531 was filed on 27-sep-2017.The first supplemental mdr 2432235-2017-00531_s1 was filed on 27-oct-2017.The second supplemental mdr 2432235-2017-00531_s2 was filed on 07-nov-2017.The third supplemental mdr 2432235-2017-00531_s3 was filed on 21-dec-2017.The fourth supplemental mdr 2432235-2017-00531_s4 was filed on 16-apr-2018.The fifth supplemental mdr 2432235-2017-00531_s5 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.Result and conclusion codes have been updated in section h6.Mdrs 2432235-2017-00599_s4, mdr 2432235-2017-00625_s4, mdr 2432235-2017-00660_s3, mdr 2432235-2018-00156_s2, 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.

Manufacturer Narrative

The initial mdr 2432235-2017-00531 was filed on 27-sep-2017.The first supplemental mdr 2432235-2017-00531_s1 was filed on 27-oct-2017.The second supplemental mdr 2432235-2017-00531_s2 was filed on 07-nov-2017.The third supplemental mdr 2432235-2017-00531_s3 was filed on 21-dec-2017.The fourth supplemental mdr 2432235-2017-00531_s4 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 2432235-2017-00599_s3, mdr 2432235-2017-00625_s3, mdr 2432235-2017-00660_s2, and mdr 2432235-2018-00156_s1 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: 6899064
• MDR Text Key: 87629307
• Report Number: 2432235-2017-00531
• Device Sequence Number: 4
• 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,Followup,Followup
• Report Date: 07/23/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/02/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 10/03/2017; 10/17/2017; 11/28/2017; 04/05/2018; 05/11/2018; 05/07/2018
• Supplement Dates FDA Received: 10/27/2017; 11/07/2017; 12/21/2017; 04/16/2018; 06/05/2018; 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1