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

Model Number 9500-27

Device Problem Invalid Sensing (2293)

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870); Hypoglycemia (1912); Damage to Ligament(s) (1952)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that they experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and an adverse event on (b)(6) 2016.The sensor was inserted into the abdomen on (b)(6) 2016.The patient stated that he was getting ready to go to work and his blood sugar was reading at 109mg/dl, per the cgm, but it was not correct.Patient's blood sugar was low, 41mg/dl, per a fingerstick reading.Patient stated that before he could get enough into his system to bring his blood sugar back to a safe number his legs gave out and he became incoherent.The patient rolled his ankle and severely bruised his side from trying to catch himself.The patient had to make a trip to the emergency room (er) for x-rays and glucose.The patient sustained torn ligaments and a small fracture in his foot.At the time of contact, the patient was bruised and had a brace.No additional event or patient information was provided.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING 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: 5750022
• MDR Text Key: 48189253
• Report Number: 3004753838-2016-38625
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(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: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 95