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

Model Number	7308
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	01/03/2020
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 obtained a blood glucose reading of 20 mg/dl at 1:06 p.M.On the contour next link meter.The customer had no symptoms of hypoglycemia.The customer performed another testing on the contour next one meter and obtained a reading of 92 mg/dl at 1:15 p.M.The customer then performed a repeat testing on the contour next link meter and obtained a reading of 166 mg/dl at 1:18 p.M.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 returned the suspected contour next link and contour next one meters for evaluation.The customer also returned the suspected contour next test strips from lot # 9apeg13b.Four of six returned test strips were already inoculated with blood and could not be used for testing.Therefore, an in-house testing was performed using the returned meters with in-house contour next test strips from the same lot #.Only 1 returned test strip was available for testing with each meter.All readings obtained with returned and in-house test strips gave 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: 9638145
• Report Number: 1810909-2020-00051
• Device Sequence Number: 2678421
• Product Code: NBW
• UDI-Device Identifier: 10301937308502
• UDI-Public: 10301937308502
• 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
• Report Date (Section B): 01/03/2020

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: 7308
• Device Catalogue Number: 7308
• Device Lot Number: 9APEG13B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR