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

Model Number	7313
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
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 received blood glucose readings of 125 mg/dl at 11:04 p.M.On the contour next ez meter and 453 mg/dl at 11:09 a.M.On a non-ascensia meter.There was no allegation of an adverse event.The device is not expected to be returned for the evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer stated that she did not wash her hands prior to testing.As per the contour next ez blood glucose monitoring system user guide "always wash your hands well with soap and water before and after testing, handling the meter, lancing device, or test strips.".
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Lot # 9apec52d involved in the event occurrence expired in jan-2021.Therefore, the in-house contour next ez meter was tested with the in-house contour next test strips from lot # 9gpeg02b (expiration date: jul-2021) 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 10595
• MDR Report Key: 10553829
• Report Number: 1810909-2020-00479
• Device Sequence Number: 11555435
• Product Code: NBW
• UDI-Device Identifier: 10301937313100
• UDI-Public: 10301937313100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• 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,Followup
• Report Date (Section B): 08/21/2020

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: 01/31/2021
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 9APEC52D
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/19/2020; 05/19/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 09/23/2020; 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR