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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 Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2021
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 available, no information was captured (model #, lot # and expiration date), and the device manufacture date could not be determined.
 
Event Description
The customer alleged that there was no labeling information (model #, lot # and expiration date) on the bottle of the contour next test strips.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement test strips were sent to the customer.
 
Manufacturer Narrative
The customer did not return the device for evaluation.Additionally, as the test strips lot # was not provided, no further investigation could be performed.
 
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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 Key11273732
MDR Text Key234837763
Report Number1810909-2021-00063
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 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
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 Received04/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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