MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number N/A

Device Problems Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hypoglycemia (1912); No Consequences Or Impact To Patient (2199); Loss of consciousness (2418); Blood Loss (2597)

Event Date 06/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver was not responding.No additional event or patient information is available.No product or data were provided for evaluation.The confirmation of  the complaint is undetermined.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on 06/26/2018, that on (b)(6) 2018, an adverse event occurred.The patient stated on (b)(6) 2018 they were using the bathroom and when they got up, they fell and remembers waking up in a puddle of blood.She indicated that the bleeding was from a surgical wound from knee surgery that they had a month prior to the event.The patient¿s grandson found her and called for an ambulance and when the paramedics arrived, they tested the patient¿s blood glucose and the meter was reading 33mg/dl.They immediately administered the patient with glucose and transported her to the hospital.The patient was moved from the emergency room (er) to orthopedics to have the open wound treated.They patient was in the hospital until (b)(6) 2018 and moved to an acute care facility.There was no allegation against the device as the patient was not wearing the dexcom at the time of event due to previously reported issues with the device.At the time of contact, the patient was doing well.No additional patient or event information is available.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7689441
• MDR Text Key: 114066794
• Report Number: 3004753838-2018-076946
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

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 Model Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 74 YR
• Patient Weight: 110