MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXTONE METER KIT AND SOLUTION; GLUCOSE DEHYDROGENASE, GLUCOSE

Model Number 90001779 7824

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

Event Type  malfunction  

Event Description

Ascensia diabetes care control solution product 7109b, ndc# 0193-7109-01 is incorrectly labeled and very poorly documented, resulting in my inability to use the purchased product.It states that it is: for use with all contour blood glucose monitoring systems.I have the contour next one meter.After 3 emails and 3 calls to their support line, the rep said that i needed a different control solution, because it produces an error on the meter.I searched the included documentation and on the product site to find what solution should be used, but it was not listed.Additionally, the meter kit shows that it includes 20 test strips but it only contains one box of 10.The kit is ndc# 0193-7824-01.On my first 2 calls to their support line, neither of the reps had a clue about what i was saying.The english was fine, but they were unable to comprehend the issue whatsoever.That indicates poor training, poor quality control and that customer service is not competent in resolving problems.Because of problems with the meter which prompted me to use the control solution, i am forced to trash the purchased control solution and likely discard the meter kit, and 70 additional test strips because of the inability to get an accurate reading.I recommend an inquiry to the procedures, training and products of the company to prevent injury to other users of the product.Fda safety report id# (b)(4).

• Brand Name: CONTOUR NEXTONE METER KIT AND SOLUTION
• Type of Device: GLUCOSE DEHYDROGENASE, GLUCOSE
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.
• MDR Report Key: 12467106
• MDR Text Key: 271662198
• Report Number: MW5103893
• Device Sequence Number: 3
• Product Code: LFR
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/09/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 90001779 7824
• Device Catalogue Number: NDC0193-71090-01
• Device Lot Number: 1BW2C29
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 102