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

Model Number	9632
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
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.
Event or Problem Description
The customer reported that the blood glucose readings between the contour next link meter and insulin pump were inconsistent.The customer stated the she performed a test on the meter and received a reading, which was transferred as low reading on the pump.The customer stated that the reading on the meter was not low.The low reading for the customer is below 70 mg/dl.The customer had no symptoms of hypoglycemia.There was no allegation of an adverse event.The customer was advised to return the meter for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, the in-house contour next link meter was tested with the in-house contour next test strips, which gave a satisfactory performance.The customer's allegation could not be replicated with the in-house meter.The customer has the ability to set her own low alert between 54 mg/dl and 99 mg/dl.The customer's low alert setting could not be verified without the suspected meter.Additionally, a device history record was reviewed for the suspected contour next link meter and no manufacturing anomalies were found.

• 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
• MDR Report Key: 9929699
• Report Number: 1810909-2020-00170
• Device Sequence Number: 19020671
• Product Code: NBW
• UDI-Device Identifier: 00301939632011
• UDI-Public: 00301939632011
• 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): 03/09/2020

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: 9632
• Device Catalogue Number: 9632
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR