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

Model Number	7311
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Headache (1880)
Date of Event	10/24/2020
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.This event is related to mdr #: 1810909-2020-00602.
Event or Problem Description
An advocate called on behalf of the customer to report that the customer obtained blood glucose readings of 518 mg/dl at 4:21 p.M.And 160 mg/dl at 4:22 p.M.On the contour next ez meter while using the contour next test strips from lot # 0apeg18b.Additionally, the customer obtained blood glucose readings of hi (indicative of a reading above 600 mg/dl) at 5:15 p.M.With the contour next ez meter while using the contour next test strips from lot # 0apeg18b, and 214 mg/dl at 5:16 p.M.And 247 mg/dl at 5:17 p.M.On the contour next link 2.4 meter while using the contour next test strips from lot # 9apea05a.The customer was experiencing a headache.He ate a few bites of a light cookie 5 minutes before eating his meal.The customer's headache subsided after he had his meal.There was no allegation of an adverse event.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 returned the suspected contour next ez meter and contour next test strips from lot #s 9apea05a and 0apeg18b for evaluation.The returned test strips from lot # 9apea05a expired in jan-2021, therefore, the test strips from this lot were not used for in-house testing.The returned meter was tested with the returned test strips from lot # 0apeg18b using a blood sample, which gave a satisfactory performance.Additionally, a device history record was reviewed for the suspected contour next ez 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 10595
• MDR Report Key: 10830101
• Report Number: 1810909-2020-00603
• Device Sequence Number: 2960402
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2020

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: 01/31/2022
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 0APEG18B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 10/24/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR