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

Model Number 9697

Device Problem Low Readings (2460)

Patient Problems Head Injury (1879); Loss of consciousness (2418)

Event Date 05/31/2020

Event Type  Injury  

Manufacturer Narrative

The patient/family was the initial reporter, so personal information was not entered.No information was captured in section as the customer's weight was not provided.

Event Description

An advocate reported that the customer obtained a low reading on the contour next meter.No specific reading was provided.As the reading on the meter was low, she did not take her medication and experienced symptoms of hyperglycemia.The customer passed out and injured her head.The customer was taken to the hospital and her blood sugar levels were high.The customer was admitted to the rehabilitation facility.No further event details were provided.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.Since the strip information was not provided, this report will be submitted under the meter information.

Manufacturer Narrative

The customer did not return the device for evaluation.Since the lot # of the suspected test strips was not provided, the in-house testing could not be performed.Therefore, a device history record was reviewed for the suspected contour next meter and no manufacturing anomalies were found.

• Brand Name: CONTOUR NEXT
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 10372891
• MDR Text Key: 201890215
• Report Number: 1810909-2020-00390
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00301939697010
• UDI-Public: 00301939697010
• Combination Product (y/n): N
• PMA/PMN Number: K121190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9697
• Device Catalogue Number: 9697
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 88 YR