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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT; BLOOD GLUCOSE TEST STRIPS
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ASCENSIA DIABETES CARE US INC. CONTOUR NEXT; BLOOD GLUCOSE TEST STRIPS Back to Search Results
Model Number 7278
Medical Device Problem Code Low Readings (2460)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/12/2018
Type of Reportable Event Malfunction
Event or Problem Description
The customer obtained a blood glucose reading of 45 mg/dl on a contour next one meter.Upon repeat testing within 5 minutes on a different meter, a reading of 245 mg/dl was obtained.The customer had no symptoms of hypoglycemia or hyperglycemia.The difference between the readings falls in "c" zone of the consensus error grid, making the difference clinically significant.No adverse event was alleged.The customer was advised to return the test strips for evaluation.Replacement meter and test strips were sent to the customer.
 
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Brand Name
CONTOUR NEXT
Common Device Name
BLOOD GLUCOSE TEST STRIPS
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC.
100 summit lake drive
valhalla NY 10595
MDR Report Key8232225
Report Number1810909-2019-00022
Device Sequence Number16621950
Product Code NBW
UDI-Device Identifier10301937278706
UDI-Public10301937278706
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K160682
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date (Section B) 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date11/30/2019
Device Model Number7278
Device Catalogue Number7278
Device Lot Number7LPEC426
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/12/2018
Initial Report FDA Received Date01/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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