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

Lot Number 1JPEF08A

Device Problem Unsealed Device Packaging (1444)

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

Event Date 04/19/2022

Event Type  malfunction  

Manufacturer Narrative

A device history record was reviewed for the suspected contour next test strips and no manufacturing anomalies were found.The dimensions of the carton makes it difficult for a vial cap to open after packaging when the box is sealed.The patient/family was the initial reporter, so personal information was not entered.

Event Description

The customer reported that he opened a box of the contour next test strips and the bottle was already open.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.

• 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
• Manufacturer (Section G): PHC CORPORATION (REGISTRATION NUMBER: 1000134386); 2131-1 minamigata; toon ehime, 791-0 395; JA 791-0395
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 14355393
• MDR Text Key: 291383193
• Report Number: 1810909-2022-00083
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Lot Number: 1JPEF08A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male