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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL NOVA MAX GLUCOSE TEST STRIPS
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NOVA BIOMEDICAL NOVA MAX GLUCOSE TEST STRIPS Back to Search Results
Lot Number 1020216041
Device Problems Defective Component (2292); Incorrect Or Inadequate Test Results (2456)
Patient Problem Hyperglycemia (1905)
Event Date 02/02/2017
Event Type  Injury  
Event Description
Patient here today to have his nova max glucometer check reports that he has been getting bs over 200 mg/dl fasting and sometimes glucometer reads error, when checking patient's test strips with clinic meter using control solution, results were out of range 144 mg/dl, control ranges 82-127 mg/dl, found test strips defective, checked meter and working properly, patient was given new rx for test strips and instructed to report to the pharmacy for new test strips, safe storage of glucometer/test strips reviewed with patient with handout provided, patient verbalized understanding, defective test strips lot #1020216041.Diagnosis or reason for use: diabetic.Is the product over-the-counter: no.
 
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Brand Name
NOVA MAX GLUCOSE TEST STRIPS
Type of Device
NOVA MAX
Manufacturer (Section D)
NOVA BIOMEDICAL
waltham MA 02454
MDR Report Key6308168
MDR Text Key66805703
Report NumberMW5067715
Device Sequence Number1
Product Code CGA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/28/2018
Device Lot Number1020216041
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient Weight69
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