Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT; BLOOD GLUCOSE TEST STRIPS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ASCENSIA DIABETES CARE US INC. CONTOUR NEXT; BLOOD GLUCOSE TEST STRIPS Back to Search Results
Model Number 7309
Medical Device Problem Code Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/30/2018
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
On 11:30 a.M., the customer obtained a blood glucose reading of 83 mg/dl on a contour next link meter.Within a minute, the customer performed retesting on two other contour next link meters and the readings were 276 mg/dl and 187 mg/dl.The differences between the readings fall in the "c" and "d" zones of the consensus error grid, making the differences clinically significant.No adverse event was alleged.The customer has been advised to return the test strips for evaluation.New test strips, meter and control solution were sent to the customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONTOUR NEXT
Common Device Name
BLOOD GLUCOSE TEST STRIPS
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC.
430 s beiger st
mishawaka IN 46544
MDR Report Key7845595
Report Number1826988-2018-00224
Device Sequence Number11100429
Product Code NBW
UDI-Device Identifier10301937309509
UDI-Public10301937309509
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K110894
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) 08/30/2018
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 Date06/30/2019
Device Model Number7309
Device Catalogue Number7309
Device Lot Number7FFEG01C
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/30/2018
Initial Report FDA Received Date09/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-