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

Model Number G5

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2018

Event Type  malfunction  

Event Description

Dexcom g5 receiver shows three question marks due to temporary inoperability, without giving alarm/alert/vibration.???- the problem: missing alarm for uninterpretable measured values (symbol:???) g4 and g5 give alarms for different states (high and low, fast rising and falling values/ distance alarm/ alarm for sensor failure / alarm before sensor expires after 7 days).If measured values that cannot be interpreted by the system occur, the receiver display shows three question marks.As a result, tissue glucose values and tendencies are not displayed, alarms for limit values or gradients cannot be emitted during this phase.Inexplicably, there is no alarm about the current state of inoperability of the system.That¿s where the risk lies, especially during the night.If the user were informed of the temporary loss of function by means measurement.The dexcom g4 and g5 systems have been advertised in various publications for protection against unnoticed nocturnal hypoglycemia.In my opinion, users feel completely safe.This safety is not provided when using the system in accordance with the guidelines defined by the manufacturer.Only if after a period of three hours, no values can still be interpreted by the system alarm occurs which, in my opinion, is not very sustainable.

• Brand Name: DEXCOM G5
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 8363170
• MDR Text Key: 137259239
• Report Number: MW5084256
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G5
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR