MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 RECEIVER CGM; SENSOR, GLUCOSE, INVASIVE

Model Number G5 TOUCHSCREEN RECEIVER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/10/2019

Event Type  malfunction  

Event Description

Patient damaged her dexcom g5 receiver, and requested to purchase a refurbished receiver out of pocket from dexcom.Our endocrine clinic has made multiple phone calls on her behalf and she has requested this several times as well.The patient is still awaiting, even though she tells me has already been charged for this replacement unit.Dexcom does not records of previous paperwork faxed to them to facilitate this order, nor do they seem to keep adequate records of calls made to them on this issue.I repeatedly asked to speak to the customer service reps supervisor to facilitate this, but this didn't happen.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G5 RECEIVER CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 8842200
• MDR Text Key: 152942196
• Report Number: MW5088473
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G5 TOUCHSCREEN RECEIVER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 59