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

Model Number	7309
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.Weight was left blank as the customer's weight was not provided.
Event or Problem Description
The customer reported that she obtained a difference of 30-40 mg/dl between blood glucose readings obtained on two separate contour next link meters.No specific readings were provided.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected product for evaluation.The lot # of the contour next test strips involved in the event was provided as 8epeg14b by the customer.However, the expiration date associated with the lot # was provided as 31-mar-2020.Based on the expiration date, the lot # in section d4 of the initial report was captured as 8cpeg14b, corresponding with expiration date of 31-mar-2020.Therefore, during in-house testing, test strips from both lots i.E.Lot # 8epeg14b and lot # 8cpeg14b were used for testing.An in-house testing was performed using the in-house contour next link meter with the in-house contour next test strips from both of the above mentioned lots, which gave satisfactory performance.
Additional Manufacturer Narrative
The customer returned the suspected contour next link meter for evaluation.No test strips were returned.An in-house testing was performed using the returned meter with in-house contour next test strips from lot #s 8epeg14b and 8cpeg14b, which gave satisfactory performance.

• Brand Name: CONTOUR NEXT LINK
• 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: 9481666
• Report Number: 1810909-2019-00569
• Device Sequence Number: 14147520
• Product Code: NBW
• UDI-Device Identifier: 10301937309509
• UDI-Public: 10301937309509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• 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,Followup
• Report Date (Section B): 12/02/2019

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: 03/31/2020
• Device Model Number: 7309
• Device Catalogue Number: 7309
• Device Lot Number: 8CPEG14B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 02/05/2020; 02/12/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/07/2020; 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR