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

Model Number	7311
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
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 stated that he was at the physician's office for a regular appointment where they performed blood glucose tests and obtained a difference of 40 mg/dl between the readings obtained on the contour next one meter and an alternate meter.No specific readings were provided.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the contour next link 2.4 meter for evaluation.However, the serial # of the returned meter was different from the one implicated to be involved in the event occurrence.No test strips were returned.Therefore, the returned meter was tested with the in-house contour next test strips from lot # 9kpeg02b using a blood sample, which gave a satisfactory performance.
Additional Manufacturer Narrative
The first supplemental report indicated that the customer returned the contour next link 2.4 meter for evaluation, which was different from the one implicated to be involved in the event occurrence.Upon further investigation, it was identified that the returned meter was associated with a separate event.Therefore, please disregard the investigation conclusion provided in section h10 of the first supplemental report.With regards to this event, 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#: 9kpeg02b using a blood sample, which gave a satisfactory performance.The investigation code has been updated in section h6 to reflect the correct investigation details.
Additional Manufacturer Narrative
The customer returned the suspected contour next link 2.4 meter and contour next test strips from lot # 9kpeg02b for evaluation.The returned meter was tested with the returned test strips 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: 11116037
• Report Number: 1810909-2021-00016
• Device Sequence Number: 4314577
• Product Code: NBW
• UDI-Device Identifier: 10301937311502
• UDI-Public: 10301937311502
• 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,Followup
• Report Date (Section B): 12/10/2020

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: 10/31/2021
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 9KPEG02B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 02/04/2021; 03/03/2021; 04/08/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/15/2021; 03/09/2021; 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR