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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL NOVA MAX TEST STRIPS
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NOVA BIOMEDICAL NOVA MAX TEST STRIPS Back to Search Results
Lot Number 1020415009
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 04/26/2016
Event Type  Injury  
Event Description
Pt had pcp appointment this morning and reported that her nova max meter is registering different blood sugar results.When she checks her sugar, the meter gives high results and she would check again and it will give her low results.She has been checking her sugar at different times of the day and having the same problem.Clinic meter and clinic test strips checked prior to checking pt's meter using control solution, (control range 82-127mg/dl) results 94mg/dl within range when using clinic meter and pt's test strips using control solution, results 419mg/dl out of range.Pt's test strips found defective, lot #102041509, exp 01/31/2017, test strips removed from pt and new rx for test strips given to pt and instructed to go to the pharmacy, also, reviewed safe storage for meter and test strips with handout given.
 
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Brand Name
NOVA MAX TEST STRIPS
Type of Device
NOVA MAX TEST STRIPS
Manufacturer (Section D)
NOVA BIOMEDICAL
waltham MA 02454
MDR Report Key5620430
MDR Text Key44141315
Report NumberMW5061984
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 04/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/31/2017
Device Lot Number1020415009
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
Patient Weight76
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