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

Model Number 9500-27

Device Problem Imprecision (1307)

Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199); Diabetic Ketoacidosis (2364)

Event Date 03/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The patient experienced adverse events on different days with the same device.The following reports are being submitted.(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter.No additional event or patient information is available.No data was provided for evaluation.The complaint confirmation of the reported inaccuracy could not be determined.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, via social media, that on (b)(6) 2018, the patient experienced an adverse event.The patient's daughter stated that the patient's dexcom system was not reading his high glucose readings correctly.She indicated that the patient ended up in ika with severe diabetic ketoacidosis and a heart attack.Additionally, the patient's daughter reported that the patient had several machines and they were all not reading his high glucose readings correctly.It was undetermined of what machines the patient was using.No additional patient or event information is available.

• 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: 7384060
• MDR Text Key: 103929733
• Report Number: 3004753838-2018-31825
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: 00386270000019
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2018
• 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): Other