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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC CONTOUR NEXT LINK; BLOOD GLUCOSE METER
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ASCENSIA DIABETES CARE US INC CONTOUR NEXT LINK; BLOOD GLUCOSE METER Back to Search Results
Model Number 9632
Medical Device Problem Code Missing Test Results (3267)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/25/2018
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 her daughter tests her blood 6 times a day on the contour next link.One of those days there was only one reading in the memory of the meter, and the mother witnessed the daughter performing 6 tests.The advocate also ran a blood test during the call, and was not able to see that reading in the memory either.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.
 
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Brand Name
CONTOUR NEXT LINK
Common Device Name
BLOOD GLUCOSE METER
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC
430 s beiger st
mishawaka IN 46544
MDR Report Key7709862
Report Number1826988-2018-00152
Device Sequence Number13641062
Product Code NBW
UDI-Device Identifier00301939632011
UDI-Public00301939632011
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) 06/26/2018
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 Number9632
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/26/2018
Initial Report FDA Received Date07/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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