MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOIBLE CONTINUOUS GLUCOSE MONITORING SYSTEM; CONTINOUS GLUCOSE MONITOR

Model Number 9500-27

Device Problem Detachment Of Device Component (1104)

Patient Problems Staphylococcus Aureus (2058); Scarring (2061); Foreign Body In Patient (2687)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.Product code pqf is not currently available. .

Event Description

Dexcom was made aware on 12/27/2016, that on (b)(6) 2016, the patient experienced a detached sensor wire, where the wire remained under the skin.The sensor was inserted in the patient's abdomen on (b)(6) 2016.The patient visited the doctor to surgically remove the sensor wire from the patient's skin.The patient stated that he experienced a staph infection and the doctor expects there to be permanent scarring.At time of contact the patient's condition was still letting the wound heal and expected to permanently scar.No additional event or patient information is available.No product was provided for evaluation.The reported event could not be confirmed.A root cause cannot be determined.

• Brand Name: DEXCOM G5 MOIBLE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINOUS 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: 6270785
• MDR Text Key: 65516845
• Report Number: 3004753838-2017-01118
• 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: 12/27/2016

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: 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
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 01/23/2017
• 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: 38 YR
• Patient Weight: 66