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

Model Number	7308
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Sweating (2444)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer weight was not provided.
Event or Problem Description
The customer reported that he was admitted to the hospital for a surgery, an event unrelated to diabetes.The customer obtained a blood glucose reading of 93 mg/dl at 1:59 a.M.On the contour next link 2.4 meter.The customer took insulin from the insulin pump based on the meter reading.A laboratory testing was performed at 2:09 a.M.And a reading of 57 mg/dl was obtained.The customer was experiencing symptoms of hypoglycemia such as sweating.The customer was given crackers and cookies to increase his blood glucose levels.Additionally, the customer stated that he obtained blood glucose readings of 126 mg/dl with the contour next link 2.4 meter and 50 mg/dl or 60 mg/dl with the laboratory testing.There was no allegation of an adverse event alleged.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, a 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
• MDR Report Key: 10443034
• Report Number: 1810909-2020-00427
• Device Sequence Number: 3975032
• Product Code: NBW
• UDI-Device Identifier: 10301937308502
• UDI-Public: 10301937308502
• 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): 07/31/2020

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 Expiration Date: 05/31/2021
• Device Model Number: 7308
• Device Catalogue Number: 7308
• Device Lot Number: 9EPEG12B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR