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

Lot Number 6LPEG19D

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 09/18/2017

Event Type  Death  

Manufacturer Narrative

The model# was not provided.

Event Description

The (b)(6) received a medical devices adverse incident user report stating, on (b)(6) 2017, an individual received excessive insulin from the pump, resulting in brain injury due to hypoglycemia, followed by her death on (b)(6) 2017.The contour next link 2.4 was being used in conjunction with medtronic minimed 640g insulin pump.In summary, on (b)(6), midday, the customer was found at home in a comatose state.Paramedics were called and she was taken to (b)(6) hospital.Further details were not provided.Although, at no point was the meter mentioned as being implicated in the incident, the system has not been returned for evaluation.

Manufacturer Narrative

As the ascensia devices were lost by the courier company, we requested a copy of the analysis of the insulin pump data from medtronic, the insulin pump manufacturer.The contour next link 2.4 meter sends blood glucose results wirelessly to the pump.The last 3 readings sent to the pump (september 16th at 12:44, 14:28 and 15:59) were 3.6, 3.0 and 6.7mmol/l, which would not trigger an additional insulin bolus dose.This was followed by 2 manually entered blood glucose results of 12.6 and 13.7mmol/l at 16:16 and 16:57, respectively, which were significantly higher than the readings sent by the contour next link 2.4.As these readings were manually entered, they were most probably derived from an alternative monitoring system.From the pump data it can be established that no blood glucose results were entered on the day of the hypoglycemic event, nor were there any failed attempts to send results by the contour next link 2.4 on september 16th to the 18th.It would therefore appear that the contour next link 2.4 blood glucose system was not in use at this time.

• Brand Name: CONTOUR NEXT
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• 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 ; 5743149617
• MDR Report Key: 7122395
• MDR Text Key: 95003903
• Report Number: 1826988-2017-00354
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P150001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Lot Number: 6LPEG19D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 39 YR