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 LINK 2.4; BLOOD GLUCOSE METER
  • 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 LINK 2.4; BLOOD GLUCOSE METER Back to Search Results
Model Number 6262
Medical Device Problem Code Missing Test Results (3267)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/23/2018
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
The advocate stated his daughter's contour next link 2.4 was not saving all of the blood glucose readings in memory.The daughter tests her blood glucose 4 times a day, but the meter memory shows only 1 reading per day.There was no allegation of an adverse event.The advocate was advised to return the meter for evaluation a new meter was sent to the customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONTOUR NEXT LINK 2.4
Common Device Name
BLOOD GLUCOSE METER
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC
430 s beiger st
mishawaka IN 46544
MDR Report Key7590992
Report Number1826988-2018-00111
Device Sequence Number13957886
Product Code NBW
UDI-Device Identifier00301936262013
UDI-Public00301936262013
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P150001
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) 05/24/2018
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 Model Number6262
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 05/24/2018
Supplement Date Received by Manufacturer06/20/2018
Initial Report FDA Received Date06/12/2018
Supplement Report FDA Received Date07/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-