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

Model Number	7550
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Seizures (2063); Loss of consciousness (2418); Confusion/ Disorientation (2553)
Date of Event	02/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured in section as the customer's weight was not provided.
Event or Problem Description
An advocate reported that the customer obtained a blood glucose reading of 336 mg/dl at 12:19 p.M.On the contour next link 2.4 meter.Based on this reading, the customer took an unknown amount of insulin bolus from the insulin pump.Upon repeat testing, the customer obtained the following readings: 156 mg/dl at 2:18 p.M., 79 mg/dl at 5:26 p.M.And 58 mg/dl at 10:18 p.M.With the reading of 79 mg/dl, the customer experienced symptoms of hypoglycemia such as confusion and loss of consciousness.The customer went to the hospital where he had a seizure.No treatment details for the hypoglycemic event was provided.The customer was discharged from the hospital on (b)(6) 2020.The advocate was advised to return the device for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected device for evaluation.Therefore, an in-house contour next link 2.4 meter was tested with the in-house contour next test strips from lot # 9fhe01f using a blood sample, which gave a satisfactory performance.

• 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
• MDR Report Key: 9810453
• Report Number: 1810909-2020-00121
• Device Sequence Number: 16866659
• Product Code: NBW
• UDI-Device Identifier: 10301937550154
• UDI-Public: 10301937550154
• 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): 02/10/2020

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: 06/30/2021
• Device Model Number: 7550
• Device Catalogue Number: 7550
• Device Lot Number: 9FHE01F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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
• Patient Age: 40 YR