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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM ELECTRODE, ION BASED, ENZYMATIC, CREATININE

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NOVA BIOMEDICAL CORPORATION NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM ELECTRODE, ION BASED, ENZYMATIC, CREATININE Back to Search Results
Model Number 43370
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Code Available (3191)
Event Date 11/11/2018
Event Type  malfunction  
Manufacturer Narrative
No adverse event reported, investigation ongoing.
 
Event Description
Discrepant creatinine results using nova stat sensor compared to lab reference. Patient received wrong contrast as a result.
 
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Brand NameNOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM
Type of DeviceELECTRODE, ION BASED, ENZYMATIC, CREATININE
Manufacturer (Section D)
NOVA BIOMEDICAL CORPORATION
200 prospect street
waltham MA 02454 3465
Manufacturer (Section G)
NOVA BIOMEDICAL CORPORATION
200 prospect street
waltham MA 02454 3465
Manufacturer Contact
taylor ward
200 prospect st
waltham, MA 02454-3465
7816473700
MDR Report Key8151907
MDR Text Key130052902
Report Number1219029-2018-00009
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/11/2019
Device Model Number43370
Device Lot Number4918192129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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