MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM; MDS

Model Number MT22495

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 06/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and loss of consciousness.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report a diabetic low event that occurred on (b)(6) 2015.Patient stated that at 8:00pm, she received an alert on her receiver that her blood sugar was dropping and was at 80mg/dl.The patient went to go get her fingerstick monitor from the kitchen table and somewhere between the living room and kitchen, her blood sugar dropped and she passed out and fell.The patient broke her leg in three places.Patient's husband found her right away and called the paramedics.Emt's arrived and administered iv glucose and glucose gel.Paramedics found the fracture and put her on the stretcher in the ambulance.Pt was taken to the hospital and received a ct scan.Patient was transferred to another hospital on (b)(6) 2015, where the fracture was repaired.Patient was discharged from the hospital, to a nursing home rehabilitation center a week later and then transferred to another rehab center.There was no alleged device malfunction.At the time of contact, the patient was reported as being wheelchair bound.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• Type of Device: MDS
• 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: 5411910
• MDR Text Key: 37517048
• Report Number: 3004753838-2016-00834
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000156
• UDI-Public: (01)00386270000156(241)MT22495(10)NI(17)NI
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STR-DR-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other
• Patient Age: 83 YR
• Patient Weight: 90