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

Model Number 7080G

Device Problem Invalid Sensing (2293)

Patient Problems Headache (1880); Hypoglycemia (1912); Blurred Vision (2137)

Event Date 05/13/2017

Event Type  Injury  

Event Description

The advocate stated the customer received a blood glucose reading of 40mg/dl on the contour.He experienced a headache and blurry vision, which he attributed to low blood glucose.Paramedics were called and retested the customer with their meter.The reading was 95mg/dl.The customer received no treatment and the symptoms continued.Further information was not provided.The difference between the readings falls in the "c" zone of the consensus error grid, making the difference clinically significant.Advocate was advised to return the strips for investigation.New meter and strips were sent to the customer.

• Brand Name: CONTOUR
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• 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: 6619175
• MDR Text Key: 76887951
• Report Number: 1826988-2017-00178
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 10301937080507
• UDI-Public: (01)10301937080507(17)181130(10)DW6LJ3A06C
• Combination Product (y/n): N
• PMA/PMN Number: K062058
• 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,Followup
• Report Date: 05/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Model Number: 7080G
• Device Lot Number: 6LJ3A06C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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