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	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 weight was not provided.This event is related to mdr # 1810909-2020-00202.
Event or Problem Description
The customer reported that she performed a blood glucose test and obtained a reading of 53 mg/dl on the contour next one meter.The meter automatically marked it as a control test, so the reading will be displayed as a control result when accessing the meter's memory.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next one meter for evaluation.No test strips were returned.Therefore, the in-house contour next test strips from lot # 9fped02b were used to perform testing.The returned meter was tested with the in-house test strips, which gave a satisfactory performance.All blood glucose readings obtained during in-house testing were properly marked as blood results in the meter's memory.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, the in-house contour next one meter was tested with the in-house contour next test strips from lot # 9fped02b, which gave a satisfactory performance.All blood glucose readings obtained during in-house testing were properly marked as blood results in the meter's memory.Additionally, a device history record was reviewed for the suspected contour next one 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
• MDR Report Key: 9977164
• Report Number: 1810909-2020-00201
• Device Sequence Number: 14015214
• Product Code: NBW
• UDI-Device Identifier: 10301937308502
• UDI-Public: 10301937308502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160682
• 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): 03/25/2020

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: 06/01/2019
• Device Model Number: 7308
• Device Catalogue Number: 7308
• Device Lot Number: 9FPED02B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 08/27/2020; 10/08/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 09/01/2020; 10/22/2020
• 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