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

Model Number	9632
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Arthralgia (2355)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that his contour next link meter had a frozen display and he was unable to manually turn it off.During troubleshooting, the customer was asked to reset the meter and it turned off.The customer inserted a test strip into the meter port and the display turned on.At 6:05 p.M., the customer performed a test and obtained a blood glucose reading of 426 mg/dl.After this reading, the customer was having symptoms such as feeling sick to his stomach, joint soreness, cotton mouth, and thirstiness.At around 6:00 p.M., the customer took 6.8 units of humalog.After 30 minutes, the customer's symptoms subsided and he was feeling fine.The customer was advised to return the meter for evaluation.A replacement meter was sent to the customer.
Additional Manufacturer Narrative
Serial number of the initial report indicates the serial number of contour next link meter as (b)(4).The correct serial number is (b)(4).Serial number has been updated with this information.

• Brand Name: CONTOUR NEXT LINK
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 8068590
• Report Number: 1810909-2018-00078
• Device Sequence Number: 2279815
• Product Code: NBW
• UDI-Device Identifier: 00301939632011
• UDI-Public: 00301939632011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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 Model Number: 9632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1