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

Model Number 9740

Device Problem Invalid Sensing (2293)

Patient Problems Headache (1880); Hypoglycemia (1912)

Event Date 05/07/2017

Event Type  malfunction  

Event Description

Advocate stated her sister received a blood glucose reading of 180mg/dl on the contour next link, retested on a contour next one and the reading was 70mg/dl.She had a headache and felt shaky, which normally indicated low blood glucose.The difference between the readings falls in the "c" zone of the consensus error grid, making the difference clinically significant.There was no evidence of an adverse event.The test strips were not expected to be returned.Strip information was not available.A new meter was sent to the customer.

• Brand Name: CONTOUR NEXT LINK
• 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 ; 5742567719
• MDR Report Key: 6660827
• MDR Text Key: 78374257
• Report Number: 1826988-2017-00207
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110894
• 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: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9740
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2015
• 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