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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 405
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SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 405 Back to Search Results
Catalog Number 10320055
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2014
Event Type  Other  
Event Description
Customer reported discordant sodium (na+) result on the instrument.Customer reported that instrument displayed d2 excessive drift errors for sodium, potassium and chloride analytes.There was no report of injury due to this event.
 
Manufacturer Narrative
Customer indicated that they ran a patient serum sample on the instrument.According to rapidpoint 405 operator's manual, arterial blood, venous or mixed venous blood and capillary blood are the only approved sample type on the instrument.Serum sample is not an approved sample type on the instrument.Instrument is performing as intended.
 
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Brand Name
RAPIDPOINT 405
Type of Device
RAPIDPOINT 405
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict ave.
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
northern road
sudbury, suffolk CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steven andberg
2 edgewater dr.
norwood, MA 02062
7812693655
MDR Report Key3683881
MDR Text Key19761791
Report Number1217157-2014-00003
Device Sequence Number1
Product Code GKR
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K020616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10320055
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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