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

Model Number 9628

Device Problem Nonstandard Device (1420)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

No information was captured in sections age or date of birth and weight as the customer's age and weight were not provided.

Event Description

A healthcare professional (hcp) called on behalf of the customer to report that he purchased a contour next ez meter in canada and found that the meter was reading in mg/dl instead of mmol/l.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.A replacement meter was sent to the customer.

Manufacturer Narrative

The customer did not return the device for evaluation.Therefore, a device history record was reviewed for the suspected contour next ez meter and it was determined that the meter was destined for the us market and was distributed in the us.The issue occurred outside ascensia control.

• Brand Name: CONTOUR NEXT EZ
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): PHC CORPORATION (REGISTRATION #: 3004167884); 110 oaza-inoshiri-aza; -nishiueno, wakimachi; mima tokusima, 779-3 603; JA 779-3603
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 15924040
• MDR Text Key: 307995659
• Report Number: 1810909-2022-00197
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 40301939628012
• UDI-Public: 00301939628014
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K111268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9628
• Device Catalogue Number: 9628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male