MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC CONTOUR XT; BLOOD GLUCOSE METER

Model Number 9634

Device Problem Packaging Problem (3007)

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

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

In some countries outside the us, customer information is not provided due to privacy laws.

Event Description

A sales representative in (b)(4) retrieved a contour xt kit from a pharmacy that was labeled incorrectly.The shipper, which was supposed to contain german kits reading in mg/dl, contained one contour xt meter kit where the carton was labeled for the nordic countries, but the side label that is applied to the carton had a german language sku with the lot number of the kit, along with the internal meter information.The nordic kit carton is labeled as mmol/l and displays a mmol/l meter on the front of the carton.The german side label references mg/dl and the meter inside the kit is in mg/dl, and the accessories inside the kit are in german.The kit had not been distributed to an end user.The kit was expected to be returned for investigation.

• Brand Name: CONTOUR XT
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• Manufacturer (Section G): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• Manufacturer Contact: jeri messmore ; 430 s beiger st; mishawaka, IN 46544 ; 5743149617
• MDR Report Key: 7630033
• MDR Text Key: 112420066
• Report Number: 1826988-2018-00141
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 10301937314015
• UDI-Public: 10301937314015
• Combination Product (y/n): N
• PMA/PMN Number: K111268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9634
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1