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

Model Number	7309
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418); Confusion/ Disorientation (2553)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not wash his hands prior to testing.As per the contour next link 2.4 blood glucose monitoring system user guide, "wash hands and dry well before handling to keep the meter and test strips free of water, oils and other contaminants." the precautions section mentions "follow all instructions for use and care exactly as described to help avoid inaccurate results." the patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's weight was not provided.
Event or Problem Description
The customer reported that he obtained a blood glucose reading of 118 mg/dl at 1:00 p.M.On the contour next link 2.4 meter.The customer did not eat anything all day and did not take insulin.The customer went to sleep and started experiencing symptoms of hypoglycemia, so the customer's brother called the paramedics.When the paramedics arrived, the customer was unconscious and unresponsive.The paramedics performed testing with their glucose monitoring system and obtained a reading below 50 mg/dl.The paramedics brought the customer back to consciousness.The treatment provided by the paramedics to bring the customer back to consciousness was not provided.Another testing was performed with the contour next link 2.4 meter, and a reading of 214 mg/dl at 1:46 p.M.Was obtained, while the reading with the paramedic's glucose monitoring system was above 50 mg/dl.The customer was still feeling disoriented, sweaty, and confused.The paramedics gave him juice and peanut butter jelly after which he recovered well.The customer was advised to return the device for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next link 2.4 meter for evaluation.The customer also returned the suspected contour next test strips from lot # 8kpeg12c.However, the returned test strips expired in oct-2020.Therefore, the returned meter was tested with the in-house contour next test strips from lot # 9kpeg02b using a blood sample, which gave a satisfactory performance.Additionally, the device history record was reviewed for the suspected contour next link 2.4 meter and no manufacturing anomalies were found.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 10869361
• Report Number: 1810909-2020-00616
• Device Sequence Number: 16794723
• Product Code: NBW
• UDI-Device Identifier: 10301937309509
• UDI-Public: 10301937309509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: 10/31/2020
• Device Model Number: 7309
• Device Catalogue Number: 7309
• Device Lot Number: 8KPEG12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR