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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 11/02/2017
Event Type  malfunction  
Manufacturer Narrative
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 2432235-2017-00531_s4, mdr 2432235-2017-00599_s2, mdr 2432235-2017-00660_s1, and mdr 2432235-2018-00156 were filed for the same issue.
 
Manufacturer Narrative
The initial mdr 2432235-2017-00625 was filed on 27-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 2432235-2017-00531_s3 was filed for the event occurred on (b)(6) 2017. Mdr 2432235-2017-00599_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. Additionally, alpha-fetoprotein result of 1. 5 was reported to the physician(s) for the sample in question.
 
Event Description
One of the repeat results for alpha-fetoprotein was reported to the physician(s).
 
Manufacturer Narrative
A siemens customer service engineer (cse) was at the customer site. The cse ran dry test, wet water test and wet wash1 test in replicates of thirty and used laboratory water as sample to run afp and cardiac troponin i. The cse determined that there were solution stain marks underneath the wash manifold near acid probe. Additionally, the cse found that during the daily cleaning procedure the aspirate probe 3 was overflowing. There was no overflow during the sample processing. A siemens headquarters support center (hsc) specialist stated that the residual film around the wash 1 dispense port could be the result of wicking from droplets accumulating on the port. The hsc specialist also stated that as the first result was discordant and subsequent results were correct, it may indicate that there is loss of prime of the wash fluid at dispense port 1 or 3. The cause of the imprecise afp results on one patient sample is unknown. Siemens is investigating the issue. Mdr 2432235-2017-00531 was filed for the event occurred on (b)(6) 2017. Mdr 2432235-2017-00599 was filed for the event occurred on (b)(6) 2017.
 
Event Description
Imprecise alpha-fetoprotein (afp) results were obtained on one patient sample on an advia centaur xpt instrument. The sample was repeated twice, resulting lower. It is unknown if the sample was repeated on the same instrument or alternate instrument. It is unknown if the initial or repeat result was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the imprecise afp result.
 
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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 Key7060697
MDR Text Key250774580
Report Number2432235-2017-00625
Device Sequence Number0
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
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2017
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? No
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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