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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY XPT

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SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY XPT Back to Search Results
Model Number ADVIA CHEMISTRY XPT
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2017
Event Type  malfunction  
Manufacturer Narrative
The customer contacted the siemens customer care center (ccc).The customer ran quality controls, resulting with error flags.A siemens customer service engineer (cse) was at the customer site.After inspecting the instrument, the cse replaced the reagent probe 2 mix paddle, solenoid reagent probe valve 2, and lamp.The cse checked all valves.The customer ran quality control (qc), resulting acceptable.The cause of the discordant, falsely elevated po4 result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
 
Event Description
A discordant, falsely elevated inorganic phosphorus (po4) result was obtained on a patient sample on an advia chemistry xpt instrument.The discordant result was not reported to the physician(s).The sample was repeated on an alternate instrument, resulting lower.The repeated result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant falsely elevated po4 result.
 
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Brand Name
ADVIA CHEMISTRY XPT
Type of Device
ADVIA CHEMISTRY XPT
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict avenue
tarrytown NY 10591
Manufacturer (Section G)
JEOL LTD
registration number: 300363768
3-1-2 musashino akishima
tokyo 196-8558,
JA  
Manufacturer Contact
margarita karan
511 benedict avenue
tarrytown, NY 10591
9145243105
MDR Report Key6884309
MDR Text Key88070838
Report Number2432235-2017-00519
Device Sequence Number0
Product Code CEO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990346
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Health Professional
Type of Report Initial
Report Date 09/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2017
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberADVIA CHEMISTRY XPT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/29/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/10/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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