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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC CONTOUR; BLOOD GLUCOSE TEST STRIPS
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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 03/11/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The patient was also the initial reporter, so personal information was not entered.
 
Event or Problem Description
The customer ran a blood test on the contour.The meter automatically marked it as a control test, which will be displayed as a control result when accessing the meter's memory.No adverse event was alleged.The customer was advised to return the strips for evaluation.New strips and meter were sent to him.
 
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Brand Name
CONTOUR
Common Device Name
BLOOD GLUCOSE TEST STRIPS
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC
430 s beiger st
mishawaka IN 46544
MDR Report Key7369868
Report Number1826988-2018-00045
Device Sequence Number13462633
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,Followup
Report Date (Section B) 03/11/2018
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 Date04/30/2019
Device Model Number7097C
Device Catalogue Number7097C
Device Lot Number7DJ3A03B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/11/2018
Supplement Date Received by Manufacturer03/30/2018
Initial Report FDA Received Date03/26/2018
Supplement Report FDA Received Date04/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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