MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT LINK 2.4; BLOOD GLUCOSE METER

Model Number 6260

Device Problem Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2020

Event Type  malfunction  

Manufacturer Narrative

The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's weight was not provided.This event is related to mdr # 1810909-2020-00546.

Event Description

The customer reported that her contour next link 2.4 meter was transferring the blood glucose readings twice to her connected insulin pump.The customer provided the example where blood glucose readings of 168 mg/dl and 268 mg/dl were obtained and the insulin pump delivered 1.6 units of insulin and 4.6 units of insulin respectively.The customer stated that the insulin was received based on the first reading.No insulin was received based on the duplicate reading sent to the insulin pump.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.

Manufacturer Narrative

The customer returned the suspected contour next link 2.4 meter for evaluation.No test strips were returned.The meter service mode was run and no anomalies were found.The returned meter was tested with the in-house contour next test strips and in-house breeze 2 control solution to simulate as blood.Which gave a satisfactory performance.The returned meter was connected with a reference insulin pump.The simulated blood glucose readings were properly transferred to the insulin pump.The meter did not send duplicated results to the insulin pump.

• 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 Key: 10680235
• MDR Text Key: 213692495
• Report Number: 1810909-2020-00547
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00301936260019
• UDI-Public: 00301936260019
• Combination Product (y/n): N
• PMA/PMN Number: P150001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6260
• Device Catalogue Number: 6260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2021
• Date Manufacturer Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR