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

Lot Number 0FPEC05A

Device Problem Missing Information (4053)

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

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The patient/family was the initial reporter ,so personal information was not entered.No information was captured in as the customer's age and weight were not provided.Since the product information was not available, the model #, lot # and expiration date was left blank, and the device manufacture date could not be determined.

Event Description

The customer from canada alleged that there was no labeling information (lot #, expiration date and control ranges) on the bottle of the contour next test strips.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement test strips were sent to the customer.

Manufacturer Narrative

The customer returned the suspected contour next test strips for evaluation.The customer's allegation of missing information on the label of the contour next test strips was verified.However, from the bottom of the vial, it was determined that the lot # of the returned test strips was 0fpec05.The device history record and label scans for the contour next test strips with lot # 0fpec05a were reviewed and no labeling issues were identified.Additionally, during the production, a vision inspection test is performed and any blank labels are rejected for inspection.It is possible that with the use of alcohol or other disinfecting agents being used by the customer, the labelling was worn off.Lot # and expiration date in section d4 and device manufacture date in section h4 have been updated.

• 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: 11405012
• MDR Text Key: 234460543
• Report Number: 1810909-2021-00119
• 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,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Lot Number: 0FPEC05A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1