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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 High Readings (2459)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/01/2018
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
At 2:38 p.M., the customer obtained a blood glucose reading of 418 mg/dl on a contour next link meter.Within 10 minutes, the customer performed retesting on a different contour next meter and obtained a reading of 120 mg/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.Specific strip information was not provided.Since the strip information was not provided, this report will be submitted under the meter information.The product is not expected to be returned.A replacement 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.
100 summit lake drive
valhalla NY 10595
MDR Report Key7854965
Report Number1810909-2018-00001
Device Sequence Number11254369
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) 09/04/2018
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 09/04/2018
Initial Report FDA Received Date09/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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