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

Model Number 9500-27

Device Problems Imprecision (1307); Use of Device Problem (1670)

Patient Problem Loss of consciousness (2418)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and an adverse event.Date of issue is an approximation.The sensor was inserted into the abdomen on (b)(6) 2017.The patient stated that the cgm was reading 298mg/dl and based on the cgm value, administered himself with insulin.After administering himself with insulin, he began to feel faint and did a finger stick that read 185mg/dl.The patient ended up fainting and the patient's wife called the emergency medical technicians (emt) and when the emts arrived, the patient's blood sugar was 23mg/dl.The patient was rushed to the hospital and was given a bag and a half of saline.The patient was in the hospital for a day and a half and then was released.Additionally, it was indicated that the patient suffered minor bruises from the event and the patient alleged that the inaccuracies resulted in the event.At the time of contact, the patient was in normal condition.No additional patient or event information is available.No data was provided for evaluation.The reported event of inaccuracies could not be confirmed.A root cause could not be determined.Reportedly, the patient based treatment off of cgm values.Dexcom labeling indicates: do not use the dexcom system for treatment decisions, such as how much insulin you should take.The dexcom 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 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: 6950593
• MDR Text Key: 89362652
• Report Number: 3004753838-2017-85299
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: 00386270000019
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2017
• 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: 78 YR
• Patient Weight: 78