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

Model Number	7098B
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was the initial reporter, so personal information was not entered.
Event or Problem Description
The customer received a blood glucose reading of 450mg/dl on the contour.She reacted by taking 500mg/dl of metformin.Unless her blood glucose is high, she does not take the medication.As soon as she took the medication she started to feel nauseous and her left eye was shaking, so she took a hot bath.Upon getting out of the bathtub she passed out for a couple of minutes.Her daughter help her get up, and immediately gave her orange juice and coffee.She also ate a bowl of white rice and started feeling better.She went to the hospital.Other than the doctor telling her the meter was not working and suggesting she get another one, further information was not provided.Her doctor changed her medication and removed the metformin from her prescription since she could have an allergic reaction to it.The customer was advised to return the strips for evaluation.New meter and strips were sent to her.
Additional Manufacturer Narrative
The customer returned lot number 7dj3b01a.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• MDR Report Key: 7732053
• Report Number: 1826988-2018-00165
• Device Sequence Number: 19468201
• Product Code: NBW
• UDI-Device Identifier: 10301937098502
• UDI-Public: 10301937098502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• 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): 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: 7098B
• Device Lot Number: 7DJ3B01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention