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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 7313
Medical Device Problem Code High Readings (2459)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/22/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.
 
Event or Problem Description
At 7:30 a.M., the customer obtained a blood glucose reading of 189 mg/dl on a contour next ez meter.Upon repeat testing at 7:31 a.M.On a different meter, a reading of 102 mg/dl was obtained.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation.Replacement meter, test strips and control solution 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 Key8408052
Report Number1810909-2019-00119
Device Sequence Number2326860
Product Code NBW
UDI-Device Identifier10301937313100
UDI-Public10301937313100
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K111268
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,Followup
Report Date (Section B) 02/22/2019
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 Date02/29/2020
Device Model Number7313
Device Catalogue Number7313
Device Lot Number8BPEC51D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Initial Date Received by Manufacturer 02/22/2019
Supplement Date Received by Manufacturer04/08/2019
Initial Report FDA Received Date03/11/2019
Supplement Report FDA Received Date04/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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