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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 High Readings (2459)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/13/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The patient was the initial reporter, so personal information was not entered.
 
Event or Problem Description
The customer received a blood glucose reading of 188mg/dl on the contour, retested on a different meter and the reading was 78mg/dl.The difference between the readings falls in the "c" zone of the consensus error grid, making the difference clinically significant.No adverse event was alleged.The customer was advised to return the strips for evaluation.New meter and strips 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 Key7171411
Report Number1826988-2017-00381
Device Sequence Number1485791
Product Code NBW
UDI-Device Identifier10301937097505
UDI-Public10301937097505
Combination Product (Y/N)N
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) 12/15/2017
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 Date09/30/2018
Device Model Number7097C
Device Catalogue Number7097C
Device Lot Number6JJ3D02C
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/15/2017
Initial Report FDA Received Date01/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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