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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
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's age and weight were not provided.Since the product information was not provided, model #, lot # and expiration date were not captured and device manufacture date could not be determined.
 
Event Description
The customer opened a box of contour next test strips and the bottle was already open.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation.Replacement meter kit and test strips were sent to the customer.The customer did not provide the product information.
 
Manufacturer Narrative
The customer did not return the suspected contour next test strips for evaluation.As the test strip information was not available, a device history record could not be reviewed.
 
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Brand Name
CONTOUR NEXT
Type of Device
BLOOD GLUCOSE TEST STRIPS
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC.
100 summit lake drive
valhalla NY 10595
MDR Report Key9542114
MDR Text Key173927516
Report Number1810909-2020-00006
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
K111268
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Replace
Type of Report Initial,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received03/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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