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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION NOVA STAT PROFILE CRITICAL CARE XPRESS CLINICAL CHEMISTRY CREATININE TEST SYSTEM

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NOVA BIOMEDICAL CORPORATION NOVA STAT PROFILE CRITICAL CARE XPRESS CLINICAL CHEMISTRY CREATININE TEST SYSTEM Back to Search Results
Model Number 35942
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 04/26/2018
Event Type  malfunction  
Manufacturer Narrative
Patient's procedure was delayed for hydration therapy based on the creatinine result of 1. 7. Nova biomedical opened an internal investigation into the incident.
 
Event Description
Pt scheduled for r&l heart cath poc creatinine ran in unit and resulted at 1. 7, procedure delayed for hydration therapy.
 
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Brand NameNOVA STAT PROFILE CRITICAL CARE XPRESS
Type of DeviceCLINICAL CHEMISTRY CREATININE TEST SYSTEM
Manufacturer (Section D)
NOVA BIOMEDICAL CORPORATION
200 prospect street
waltham MA 02453 3465
Manufacturer (Section G)
NOVA BIOMEDICAL CORP.
200 prospect st
waltham MA 02453
Manufacturer Contact
taylor ward
200 prospect st
waltham, MA 02453
7816473700
MDR Report Key7694958
MDR Text Key114677454
Report Number1219029-2018-00001
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K20297
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number35942
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/11/2018
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
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/17/2018 Patient Sequence Number: 1
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