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

Model Number	7308
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) was reviewed for the suspected contour next test strips, which did not verify the customer's allegation of receiving an incorrect quantity of test strips.Additionally, no manufacturing anomalies were found with the dhr review.There is a robust manufacturing method for removing the bottles with open caps.The procedure for the auto line instructs clearing the jam and checking for damaged vials.No jams were found during the processing.This is the only point where a carton could be opened and damaged.Therefore, it was concluded that the test strip bottle was tampered with after leaving the manufacturer's control.The patient/family was the initial reporter, so personal information was not entered.The customer's weight was not provided.
Event or Problem Description
The customer reported that the box and bottle of contour next test strips were crushed and already open.The customer also stated that there were only 30 test strips in the bottle which should have 50 test strips.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.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 10830081
• Report Number: 1810909-2020-00593
• Device Sequence Number: 2960396
• Product Code: NBW
• UDI-Device Identifier: 10301937308502
• UDI-Public: 10301937308502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: 7308
• Device Catalogue Number: 7308
• Device Lot Number: 0FPEF05A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR