MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT LINK 2.4; BLOOD GLUCOSE METER

Model Number	6262
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Headache (1880); Hypoglycemia (1912)
Date of Event	01/27/2020
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's weight was not provided.
Event or Problem Description
The customer reported that she was at the hospital due to her diabetes.The customer stated that the hospital visit was not related to the readings of her contour next link 2.4 blood glucose monitoring system.While at the hospital, the customer performed a blood glucose testing using her contour next link 2.4 meter and obtained a reading of 345 mg/dl.Based on this reading, the customer received 2.5 units of insulin from her insulin pump.Within 10 minutes, a repeat testing was performed with the hospital's meter and a reading of 135 mg/dl was obtained.Three hours later, the customer was feeling unwell and had headache, which she related with the symptoms of hypoglycemia.The customer took glucose and recovered well.There was no allegation of an adverse event.The device is not expected to be returned for evaluation.Since the strip information was not provided, this report will be submitted under the meter information.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, an in-house contour next link 2.4 meter was tested with the in-house contour next test strips using a blood sample, which gave a satisfactory performance.Additionally, 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 LINK 2.4
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 9745240
• Report Number: 1810909-2020-00098
• Device Sequence Number: 1802434
• Product Code: NBW
• UDI-Device Identifier: 00301936262013
• UDI-Public: 00301936262013
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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 Model Number: 6262
• Device Catalogue Number: 6262
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR