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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT IMMUNOASSAY ANALYZER Back to Search Results
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
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
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.
 
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Brand NameADVIA CENTAUR XPT
Type of DeviceIMMUNOASSAY ANALYZER
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict ave
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS
manufacturing limited
registration number: 8020888
chapel lane, swords, co., dublin
EI
Manufacturer Contact
shweta gulati
511 benedict avenue
tarrytown, NY 10591
9145242870
MDR Report Key6899064
MDR Text Key252028404
Report Number2432235-2017-00531
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K141999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/23/2018
4 Devices were Involved in the Event: 1   2   3   4  
0 Patients were Involved in the Event:
Date FDA Received09/27/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberADVIA CENTAUR XPT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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