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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 1020215082
Device Problems High Readings (2459); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2017
Event Type  malfunction  
Event Description
Patient here today to have his nova max glucometer check reports that he has been getting bs over 350 mg/dl fasting, when checking patient's test strips with clinic meter using control solution, results were out of range 277 mg/dl, control ranges 82-127 mg/dl, found test strips defective, checked glucometer 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 # 1020215082, exp date (b)(6) 2017.Diagnosis or reason for use: diabetes.Is the product over-the-counter: no.
 
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Brand Name
NOVA MAX GLUCOSE TEST STRIPS
Type of Device
NOVA MAX GLUCOSE TEST STRIPS
Manufacturer (Section D)
NOVA BIOMEDICAL
waltham MA 02454
MDR Report Key6335803
MDR Text Key67711604
Report NumberMW5067916
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 02/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/31/2017
Device Lot Number1020215082
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
Treatment
NOVA MAX GLUCOMETER TEST STRIPS
Patient Age49 YR
Patient Weight70
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