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

Model Number 7311

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2019

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.The customer did not return the suspected product.The cause of the cap of the test strips bottle being open is unknown.

Event Description

The customer reported that she opened a box of contour next test strips and found the bottle of strips was already open.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation.Replacement test strips were sent to the customer.

Manufacturer Narrative

The customer did not return the suspected product.A device history record was reviewed for the contour next test strips lot # 8hpef02 and no manufacturing anomalies were found.The retention samples were verified to have 50 strips each in 10 bottles.An investigation was performed to verify the appearance of bottles with sampling of 5 bottles every batch.No defects for open caps were found since the start of contour next production.

Manufacturer Narrative

The customer returned contour next test strips lot # 8hpeg02a, which was different from lot # 8hpef02a indicated to be involved in the event.An in-house testing was performed using the in-house contour next meter with in-house contour next control solution and returned test strips, which gave satisfactory performance.

• 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: 8792576
• MDR Text Key: 151117502
• Report Number: 1810909-2019-00300
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 10301937311502
• UDI-Public: 10301937311502
• Combination Product (y/n): N
• PMA/PMN Number: K111268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 8HPEF02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR