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

Model Number 9500-27

Device Problems Use of Device Problem (1670); Component Missing (2306)

Patient Problem Bruise/Contusion (1754)

Event Date 03/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, the patient experienced a missing sensor wire.The sensor was inserted in the patients arm.The patient stated that she inserted the sensor in her arm on (b)(6) 2017 and the sensor did not startup, nor function.The patient stated that she contacted her health care provider (hcp) who advised her to not remove the sensor and to make an appointment for sensor removal.Date the patient contacted the hcp is unknown.The patient stated that on (b)(6) 2017, she had removed the sensor after a week of wearing the sensor that never functioned.The patient reported that she did not visualize the sensor wire at the skin side of the sensor pod when she removed the sensor pod from her arm.The patient also stated that since she did not visualize the sensor wire sticking out of her arm she used tweezers to dig into her skin in search of the missing sensor wire.The patient stated that she did not find the sensor wire and when she ran her fingertips over the area of her arm where she had worn the sensor, she did not feel the sensor wire under her skin.The patient stated that the trauma caused by using tweezers to dig under her skin caused red and purple bruising.At the time of this conversation patient stated that the bruising has almost fully resolved.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.Labeling indicates: do not insert the sensor component of the dexcom system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).The placement and insertion of the sensor component of the dexcom system is not approved for other sites.If placed in other areas, the dexcom system may not function properly.

• Brand Name: DEXCOM G5 MOBILE 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: 6455608
• MDR Text Key: 71577178
• Report Number: 3004753838-2017-23392
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5219863(17)171006
• 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: 03/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/06/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5219863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• 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
• Patient Age: 21 YR
• Patient Weight: 67