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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT LINK 2.4; BLOOD GLUCOSE METER
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ASCENSIA DIABETES CARE US INC. CONTOUR NEXT LINK 2.4; BLOOD GLUCOSE METER Back to Search Results
Device Problem Wireless Communication Problem (3283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2019
Event Type  malfunction  
Manufacturer Narrative
In some countries outside the us, customer information is not provided due to privacy laws.Sections were left blank as the customer's age, gender and weight were not provided.The model # was not provided.
 
Event Description
An advocate from (b)(6) reported that there was communication problem with the customer's contour next link 2.4 meter and the connected insulin pump.It was reported that the meter gave a message that the insulin bolus was not sent, however the pump did deliver an insulin bolus.There was no allegation of adverse event.The customer was advised to return the meter for evaluation.A replacement meter kit was sent to the customer.
 
Manufacturer Narrative
The customer returned the suspected contour next link 2.4 meter for evaluation.Upon in-house investigation, it was found that the returned meter was connected to the insulin pump and was set to "never" send results to the pump.The meter successfully connected and sent bolus to a reference insulin pump.The results also transferred to a reference pump with the meter at the maximum distance of 6 feet away from the pump.When the pump was busy with other task, an attempt was made to send a bolus to the pump, and following error message was displayed on the meter, "bolus was not sent.Make sure pump is on home screen".Multiple errors such as, e30 - check pump for status of bolus delivery, e34 - bolus was not sent, e35 - meter must be connected to a pump for bolus, and e36 - could not connect to pump were found on the meter error log.
 
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Brand Name
CONTOUR NEXT LINK 2.4
Type of Device
BLOOD GLUCOSE METER
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC.
100 summit lake drive
valhalla NY 10595
MDR Report Key9316984
MDR Text Key166361047
Report Number1810909-2019-00494
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
P150001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Remedial Action Replace
Type of Report Initial,Followup
Report Date 10/15/2019
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
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Initial Date Manufacturer Received 10/15/2019
Initial Date FDA Received11/13/2019
Supplement Dates Manufacturer Received11/14/2019
Supplement Dates FDA Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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