MAUDE Adverse Event Report: DEXCOM INC. ANIMAS VIBE SYSTEM; CONTINUOUS GLUCOSE MONITOR

Device Problem No Audible Alarm (1019)

Patient Problems Fall (1848); Head Injury (1879); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 09/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Normal reporting timeline has been exceeded due to litigation matter.Dexcom is making this report based upon the filing of the lawsuit and its initial investigation of the allegations in that lawsuit.(b)(4) -this code was used as there is no other code that indicates that a device or data investigation was unable to be conducted and therefore, there is no investigation conclusion.

Event Description

The patient alleged that she experienced a severe hypoglycemic event when using an insulin-infusion pump with invasive glucose sensor and was not alerted to her low blood glucose level.Patient further alleges that at the time of the event, she passed out, fell and severely injured her head.No additional patient information was provided.

• Brand Name: ANIMAS VIBE SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7795095
• MDR Text Key: 117559327
• Report Number: 3004753838-2018-92750
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 75