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; 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; BLOOD GLUCOSE TEST STRIPS Back to Search Results
Model Number 7097C
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 10/12/2018
Type of Reportable Event Malfunction
Event or Problem Description
The customer's caregiver reported, at 11:20 a.M., the customer obtained a blood glucose reading of 127 mg/dl on a contour meter.Upon retesting, at 11:22 a.M.On two different contour meters, the readings of 271 mg/dl and 341 mg/dl were obtained.The differences between the readings falls in zone "c" of the consensus error grid, making the differences clinically significant.No adverse event was alleged.The customer was advised to return the test strips for evaluation.Replacement meter, test strips and control solution were sent to the customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONTOUR
Common Device Name
BLOOD GLUCOSE TEST STRIPS
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC.
100 summit lake drive
valhalla NY 10595
MDR Report Key7968689
Report Number1810909-2018-00053
Device Sequence Number19252879
Product Code NBW
UDI-Device Identifier10301937097505
UDI-Public10301937097505
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K062058
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) 10/12/2018
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 Date02/29/2020
Device Model Number7097C
Device Catalogue Number7097C
Device Lot Number8BJ3E03A
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/12/2018
Initial Report FDA Received Date10/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-