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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 10/09/2017
Event Type  malfunction  
Manufacturer Narrative
The initial 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 2432235-2017-00531_s3 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
A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse replaced the aspirate probes and aspirate probe pinch valves. During the cleaning procedure, the cse noted that the aspirate probe 3 cuvette was overflowing. A siemens headquarters support center (hsc) specialist reviewed the information provided and stated that the background and precision data were acceptable. During the follow-up visit, the cse replaced the acid pump, degasser, and reagent 1 diluter. The cuvette overflow occurred during 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 discordant, falsely elevated afp result on one patient sample is unknown. Siemens is investigating the issue. Mdr 2432235-2017-00531 was filed for the same issue for the event occurred on (b)(6) 2017.
 
Event Description
A discordant, falsely elevated alpha-fetoprotein (afp) result was obtained on one patient sample on an advia centaur xpt instrument. It is unknown if the initial result was reported to the physician(s). The sample was repeated twice on the same instrument, resulting lower. The 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.
 
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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 Key7007751
MDR Text Key255934624
Report Number2432235-2017-00599
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 Received11/07/2017
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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