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 Codes	Hypoglycemia (1912); Weakness (2145)
Date of Event	05/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not wash their hands with soap and water prior to testing.As per contour next link 2.4 system user guide "always wash your hands well with soap and water before and after testing and handling the meter, lancing device, or test strips." due to the covid-19 pandemic, the investigation for this event will be delayed.We will however, send the follow-up report as soon as our laboratory services are able to return to normal.The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's age and weight were not provided.
Event or Problem Description
An advocate reported that customer obtained a blood glucose reading of 55 mg/dl on the contour next link 2.4 meter.The customer was experiencing symptoms of hypoglycemia such as weakness and she was feeling sleepy.The advocate gave 3 glucose tablets and a glass of milk to the customer.Additional testing was performed with the contour next link 2.4 meter and readings of 66 mg/dl and 61 mg/dl were obtained.Another testing was performed with the second contour next link 2.4 meter and a reading of 183 mg/dl was obtained.All readings were obtained within 10 minutes.The customer felt better after administering glucose tablets and drinking milk.The advocate 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, the in-house contour next link 2.4 meter was tested with the in-house contour next test strips from lot # 9kpeg02b using a blood sample, as the contour next test strips from lot # 8kped11a implicated to be involved in the event expired in (b)(6) 2020.The in-house testing gave a satisfactory performance.Additionally, the device history records were reviewed for both contour next link 2.4 meters 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: 10122922
• Report Number: 1810909-2020-00290
• Device Sequence Number: 16856710
• 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): 05/09/2020

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: 10/31/2020
• Device Model Number: 7308
• Device Catalogue Number: 7308
• Device Lot Number: 8KPED11A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1