MAUDE Adverse Event Report: DEXCOM INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 9500-27

Device Problems Use of Device Problem (1670); Invalid Sensing (2293)

Patient Problems Hypoglycemia (1912); Weakness (2145); Dizziness (2194)

Event Date 04/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Dexcom was made aware on (b)(6) 2017, that on (6) 2017, the patient experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and a hypoglycemic event.The sensor was inserted into the abdomen on (b)(6) 2017.The patient indicated that her cgm read 241mg/dl with a single arrow pointed down.She then took a finger stick which read 91mg/dl.She drank juice and a few minutes later the cgm showed the double arrow pointed down.She then went downstairs to a neighbor (retired nurse) for help.The patient indicated that she could barely walk or talk.Additionally, the patient indicated that she felt dizzy and weak.The cgm alerted for the ultra low alarm (55 mg/dl).The neighbor gave the patient orange juice.Soon after, the patient's son showed up and called the paramedics.The patient's son helped the patient back to her apartment to wait for the paramedics.The paramedics checked the patient's bg, which was 72 mg/dl.The patient's son took the patient to the hospital.During the intake at the hospital, the nurse took a bg reading and the patient was at 170 mg/dl.There was no treatment given.Patient was released from the hospital the same day and was driven home by her son.At the time of contact, the patient was feeling great.No additional patient or event information is available.The patient based treatment off of cgm values.Labeling indicates: do not use the dexcom g4 platinum system for treatment decisions, such as how much insulin you should take.The dexcom g4 platinum system does not replace a blood glucose meter.Always use the values from your blood glucose meter for treatment decisions.Blood glucose values may differ from sensor glucose readings.Using the sensor glucose readings for treatment decisions could lead to low or high blood glucose value.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 6563843
• MDR Text Key: 75046385
• Report Number: 3004753838-2017-26442
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2017
• 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): Hospitalization; Other
• Patient Age: 56 YR
• Patient Weight: 64