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

Model Number 9500-35

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the patient experienced an adverse event.The sensor was inserted into the abdomen on (b)(6) 2018.The patient's mother stated that on the evening of (b)(6) 2018, the patient received a sensor failure on the continuous glucose monitor (cgm).The patient's mother contacted the toll-free number and the operator advised her to remove the sensor.Upon removal of the sensor, the patient's mother noticed that the sensor wire was missing from the sensor.It was indicated that the sensor wire was broken in the patient's abdominal wall, which prompted the patient's mother contact the healthcare provider (hcp).On the morning of (b)(6) 2018, the patient went to the hcp and they decided to operate on the patient.During the surgery, the hcp was able to remove the sensor wire.No additional patient or event information is available.No product was provided for evaluation.The complaint confirmation was unable to be determined.A root cause could not be determined.

• Brand Name: ANIMAS VIBE SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; 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: 7365157
• MDR Text Key: 103286613
• Report Number: 3004753838-2018-29671
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2018
• Device Model Number: 9500-35
• Device Catalogue Number: STS-GL-005
• Device Lot Number: 5229195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other