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

Model Number	6203
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	08/16/2020
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
An advocate reported that the customer obtained blood glucose readings of 470 mg/dl at 1:35 p.M.And 81 mg/dl at 1:39 p.M.On the contour next link meter.There was no allegation of an adverse event.The advocate was advised to return the device for evaluation.A replacement meter kit was sent to the advocate.The test strips information provided by the customer did not belong to this event.Therefore, this report will be submitted under the meter information.
Additional Manufacturer Narrative
The customer returned the suspected contour next link meter for evaluation.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.

• Brand Name: CONTOUR NEXT LINK
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 10553826
• Report Number: 1810909-2020-00484
• Device Sequence Number: 3168305
• Product Code: NBW
• UDI-Device Identifier: 00301936203016
• UDI-Public: 00301936203016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• 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
• Report Date (Section B): 08/20/2020

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 Model Number: 6203
• Device Catalogue Number: 6203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR