MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT LINK; BLOOD GLUCOSE METER

Model Number 9632

Device Problems Failure to Power Up (1476); Device Damaged Prior to Use (2284)

Patient Problems Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 07/08/2017

Event Type  Injury  

Event Description

The advocate stated her daughter was vomiting in the morning, which she initially thought might be a stomach virus.The daughter's contour next link would not power up when an attempted was made to test her blood glucose.The previous day the meter had gotten wet when the daughter was at the pool as there was moisture under the display screen.She went almost one day without insulin.The daughter was taken to the hospital and admitted to icu.Her blood glucose was approximately 1299mg/dl.She was in dka, and was given saline for dehydration and fast acting humalog.The patient was discharged two days later.The advocate was advised to return the meter.New meter and strips were sent to the customer.

• Brand Name: CONTOUR NEXT LINK
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer (Section G): ASCENSIA DIABETES CARE US INC.; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer Contact: jeri messmore ; 430 s. beiger st.; mishawaka, in 46544, us, IN 46544 ; 5743149617
• MDR Report Key: 6749927
• MDR Text Key: 81250102
• Report Number: 1826988-2017-00256
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9632
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR