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

Lot Number 0CPEG12

Device Problem Missing Information (4053)

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

Event Date 12/02/2020

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 age and weight were not provided.The model # was not provided.This event is related to mdr # 1810909-2021-00007.

Event Description

The customer alleged that there was no labeling information on the bottle of the test strips.During the call, the lot # of the test strips was verified from the bottom of the vial.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.

Manufacturer Narrative

The customer did not return the suspected contour next test strips for evaluation.Therefore, the device history record was reviewed for the suspected lot of test strips and no manufacturing anomalies were found.Additionally, the labeling scans were reviewed for the following lot #s 0cpeg12a, 0cpeg12b, 0cpeg12c, and 0cpeg12d based on the raw lot # 0cpeg12, and no labeling issues were identified.During the packaging, a vision inspection test is performed which would remove any vials if there was problem identified with the label.

• Brand Name: CONTOUR NEXT
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 11103605
• MDR Text Key: 225155240
• Report Number: 1810909-2021-00010
• Device Sequence Number: 1
• Product Code: NBW
• 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: 12/03/2020

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
• Device Expiration Date: 03/31/2022
• Device Lot Number: 0CPEG12
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 01/02/2021
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1