MAUDE Adverse Event Report: DEXCOM INC. ANIMAS VIBE; OYC

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to animas.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusion can be made at this time.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging the continuous glucose monitor (cgm) readings were inaccurate as compared to the finger stick blood glucose (bg) values.There was no indication that the product caused or contributed to an adverse event.It was indicated the following instructions were not being followed by the patient: not calibrating at least every 12.This complaint is being reported because the issue may result in the user reacting to incorrect cgm data which may lead to bg excursions.

• Brand Name: ANIMAS VIBE
• Type of Device: OYC
• Manufacturer (Section D): DEXCOM INC.; 6340 sequence dr; san diego CA 92121 4356
• Manufacturer (Section G): DEXCOM INC.; 6340 sequence dr; san diego CA 92121 4356
• Manufacturer Contact: 6340 sequence dr; san diego, CA 92121-4356
• MDR Report Key: 5748995
• MDR Text Key: 48772457
• Report Number: 2531779-2016-13271
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR