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

Model Number	7313
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	10/10/2019
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 #s 1810909-2019-00487 and 1810909-2019-00489.
Event or Problem Description
The customer obtained blood glucose readings of 55 mg/dl and 114 mg/dl on two separate contour next one meters.The customer had no symptoms of hypoglycemia, however, he drank juice to level up his blood sugar level.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next one meter and contour next test strips from lot # 9dpec51d for evaluation.Since the returned bottle of test strips had only two strips left, in-house contour next test strips were also used for testing.Also, only one of the suspected contour next one meter was returned for evaluation.An in-house testing was performed using the returned meter with returned test strips, which gave satisfactory performance.Additionally, a device history record was reviewed for the suspected contour next one, which was not returned for evaluation 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: 9296421
• Report Number: 1810909-2019-00488
• Device Sequence Number: 1962211
• Product Code: NBW
• UDI-Device Identifier: 10301937313100
• UDI-Public: 10301937313100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160682
• 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): 10/11/2019

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: 04/30/2021
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 9DPEC51D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR