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

Model Number	7277
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/14/2020
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 as the customer's weight was not provided.
Event or Problem Description
The customer reported that on (b)(6) 2020, he had problem speaking, which is a symptom of hypoglycemia for him.The customer went to the hospital where a comparison testing was performed, which gave blood glucose readings of 70 mg/dl on the contour next meter, 73 mg/dl on the contour next usb meter and 37 mg/dl on the hospital meter.All readings were obtained within 10 minutes.The customer received dextrose solution in the hospital to raise his blood sugar levels.The customer was hospitalized for 4 days.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 meter, contour next usb meter and contour next test strips from lot # 9fpec42c for evaluation.In-house test strips from lot # 9fpec42c were also used to perform testing.The returned meters were tested with the returned test strips and in-house test strips, which gave a satisfactory performance.Additionally, a device history record was reviewed for the suspected contour next test strips 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: 9835204
• Report Number: 1810909-2020-00134
• Device Sequence Number: 3068552
• Product Code: NBW
• UDI-Device Identifier: 10301937277358
• UDI-Public: 10301937277358
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: 7277
• Device Catalogue Number: 7277
• Device Lot Number: 9FPEC42C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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: 57 YR