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

Model Number	7311
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Dizziness (2194); Loss of consciousness (2418)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contact details for the initial reporter was not provided, therefore, no information was captured in section.No information was captured in section as the customer's weight was not provided.
Event or Problem Description
The customer reported that she obtained blood glucose readings of 288 mg/dl at 1:09 a.M., 301 mg/dl at 1:20 a.M., 272 mg/dl at 2:21 a.M., 263 mg/dl at 2:44 a.M., and 157 mg/dl at 8:36 a.M.On the contour next link 2.4 meter.The customer stated that she received 2 units of additional insulin from the insulin pump based on high readings.The customer experienced symptoms of hypoglycemia such as dizziness and then became unconscious.At 10 a.M., an ambulance was called and a blood glucose test was performed with the ambulance's meter, which gave a reading of 32 mg/dl.The customer was given intravenous dextrose, after which she recovered well.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next link 2.4 meter for evaluation.No test strips were returned.Therefore, the in-house test strips from lot # 9jpeg10a were used for testing.The returned meter was tested with the in-house test strips 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: 10372890
• Report Number: 1810909-2020-00382
• Device Sequence Number: 3092312
• Product Code: NBW
• UDI-Device Identifier: 10301937311502
• UDI-Public: 10301937311502
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 09/30/2021
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 9JPEG10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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: Required Intervention
• Patient Age: 74 YR