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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR; BLOOD GLUCOSE TEST STRIPS
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ASCENSIA DIABETES CARE US INC. CONTOUR; BLOOD GLUCOSE TEST STRIPS Back to Search Results
Model Number 7097C
Medical Device Problem Code Low Readings (2460)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/05/2018
Type of Reportable Event Malfunction
Event or Problem Description
The customer obtained a blood glucose reading of 41 mg/dl on a contour meter.Upon retesting on a different meter, a reading of 146 mg/dl was obtained.The customer did not feel any symptoms.The difference between the readings falls in the "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
Common Device Name
BLOOD GLUCOSE TEST STRIPS
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC.
100 summit lake drive
valhalla NY 10595
MDR Report Key8068591
Report Number1810909-2018-00080
Device Sequence Number11177145
Product Code NBW
UDI-Device Identifier10301937097505
UDI-Public10301937097505
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K062058
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) 11/06/2018
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 Date03/31/2020
Device Model Number7097C
Device Catalogue Number7097C
Device Lot Number8CJ3D02A
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/06/2018
Initial Report FDA Received Date11/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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