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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 Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation currently in process. No patient adverse event resulted from the adminstration of contrast during ct.
 
Event Description
Discrepant creatinine results on nova stat sensor resulted in adminstration of contrast during ct.
 
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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 02453 3465
Manufacturer (Section G)
NOVA BIOMEDICAL CORPORATION
200 prospect street
waltham MA 02453 3465
Manufacturer Contact
taylor ward
200 prospect st
waltham, MA 02453
7816473700
MDR Report Key8021303
MDR Text Key125662019
Report Number1219029-2018-00004
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070068
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/09/2019
Device Model Number43370
Device Lot Number4918129129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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