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

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Protective Measures Problem (3015)

Patient Problem Hypoglycemia (1912)

Event Date 08/25/2021

Event Type  Injury  

Event Description

There are 2 problems: one: dexcom sensor/transmitter does not consistently provide accurate readings - requiring 911 calls for assistance ((b)(6) 2021) when a type i diabetic is alone, sleeping, unable to wake to standard alarms and phone calls, and bs values drops and remain at dangerously low levels (40, lowest value the dexcom device can read).These events occurred in a type i diabetic with a history of many hypoglycemic-induced seizures, all which have occurred upon waking, some necessitating glucagon, some a trip to the emergency room, and some causing a slow return to normal cognition.This history of hypo-glycemic-induced seizures led the patient/family to the new dexcom and tandem technology, but it is not consistently accurate/reliable, raising concerns about its efficacy in preventing significant adverse events in type i diabetics.On (b)(6) 21 the police entered the patient's locked dorm room and assisted by waking the patient and providing fast acting carbohydrate.No additional intervention was required.Two: the tandem pump that communicates with the dexcom devices turns off appropriately but does not stop the drop in bs values, necessitating intervention from someone other than the patient (b)(6) 21 (parent), (b)(6) 2021 police/paramedic).On (b)(6) 2021 dexcom device registered approximately 130 from 6-7:30 am.By 8 am the value dropped to 78, pump stopped delivery, 15 grams of carbohydrate was given by parent, things stabilized for about 1/2 hour, but then suddenly dropped to 54, despite the pump remaining off (no basal insulin delivery) and no bolus of insulin given for approximately 10 plus hours.Further details - on other occasions, the drop in blood sugar as noted on the dexcom was not accurate ((b)(6) 2021).On (b)(6) the patient eventually woke to repeated calls and confirmed that the level was not 40, but within an acceptable range.On (b)(6) 2021, the patient did not wake to alarms or phone calls, so police and paramedics were called.Despite the device registering 40, a blood glucose value confirmed that the value was 281.These data were not known until the police/paramedics were called and woke the patient.All prolonged lows in the 40 range cause significant alarm, not only to the parents but to the police and paramedics.Dexcom tech support was called to alert them of these and related issues, including months prior to these events.Case number = (b)(4).Supervisors were involved.The most recent event on (b)(6) 2021 prompted another call to dexcom.Despite being told to ask for a supervisor, no supervisor was available within the entire united states.My call was routed to the (b)(6).Eventually, after email communication, i received a call days later.No intervention or suggestion was offered.I was informed that i would get a call back, but have not.I was made to believe that my calls were reported to the fda.Have you received reports from dexcom? type i diabetics and their families should be made aware of the fact that the stop in insulin delivery will not necessarily prevent a dangerously low blood sugar value.They should also know that not all low reading are accurate, but all cause alarm and intervention/ assessment, particularly when the patient is unable to wake or care for him/herself.Also, these problems lead to insulin dosages/pump setting that on a day-to day basis force blood sugar levels to run consistently high, so as to avoid a medical emergency/911 call.This leads to elevated hemoglobin a1c levels, which unfortunately leads to the onset of debilitating, long-term complications.See above.Fda safety report id # (b)(4).

• Brand Name: DEXCOM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12633888
• MDR Text Key: 276842160
• Report Number: MW5104619
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/11/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 19 YR
• Patient Weight: 82