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

Model Number	9740
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Dehydration (1807); Hyperglycemia (1905)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
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 the customer's weight was not provided.
Event or Problem Description
The customer reported that she obtained high readings on the contour next link 2.4 meter.The customer stated that her blood glucose reading at 4:35 p.M.Was 478 mg/dl.She performed another testing at 5:49 p.M.And obtained a reading of 538 mg/dl.While the customer was working out in the morning, she experienced symptoms of hyperglycemia such as dry mouth and feeling sick.The customer reduced her food intake.Since the customer's insulin pump was not connected to the meter, the customer manually took extra insulin based on the high readings.The customer alleged that she did not feel well even after taking extra insulin and experienced severe dehydration.She associated the incorrect dose of the insulin with the pump not being connected to the meter.At 7:00 p.M., the customer went to an emergency room.She obtained a reading of 442 mg/dl at 7:21 p.M.And was treated with insulin.The customer mentioned that she was provided a new pill of desmopressin at the doctor's office to improve her diabetes management.She was discharged on the same night.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 did not return the device for evaluation.Therefore, a device history record was reviewed for the suspected contour next link meter and no manufacturing anomalies were found.Section b5 of the initial report indicated that the customer obtained high readings on the contour next link 2.4 meter.The actual meter involved in the event occurrence is contour next link meter.Section b5 has been updated with this information.
Event or Problem Description
The customer reported that she obtained high readings on the contour next link meter.The customer stated that her blood glucose reading at 4:35 p.M.Was 478 mg/dl.She performed another testing at 5:49 p.M.And obtained a reading of 538 mg/dl.While the customer was working out in the morning, she experienced symptoms of hyperglycemia such as dry mouth and feeling sick.The customer reduced her food intake.Since the customer's insulin pump was not connected to the meter, the customer manually took extra insulin based on the high readings.The customer alleged that she did not feel well even after taking extra insulin and experienced severe dehydration.She associated the incorrect dose of the insulin with the pump not being connected to the meter.At 7:00 p.M., the customer went to an emergency room.She obtained a reading of 442 mg/dl at 7:21 p.M.And was treated with insulin.The customer mentioned that she was provided a new pill of desmopressin at the doctor's office to improve her diabetes management.She was discharged on the same night.The customer was advised to return the device for evaluation.Replacement meter and test strips were sent to the customer.

• 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: 9889482
• Report Number: 1810909-2020-00157
• Device Sequence Number: 16594319
• Product Code: NBW
• UDI-Device Identifier: 00301939740013
• UDI-Public: 00301939740013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• 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): 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 9740
• Device Catalogue Number: 9740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR