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

Model Number 9500-35

Device Problem Imprecision (1307)

Patient Problems Weakness (2145); Dizziness (2194)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient experienced inaccuracies between the continuous glucose monitor (cgm) and blood glucose (bg) meter.The sensor was inserted into the abdomen on (b)(6) 2019.On (b)(6) 2019, the patient's cgm value was 303 mg/dl but her bg value was 150 mg/dl.The time of the cgm and bg values were not provided or if the values were pre- or post-treatment.The patient was transported to the hospital by emergency medical services (ems) and was admitted overnight.She reported dizziness and weakness.It is not known if the patient experienced a hypo or hyperglycemic event.At the time of contact, that patient was in stable condition and discharged from the hospital as of (b)(6) 2019.No data or product was provided for investigation.Confirmation of the allegation was undetermined.The probable cause could not be determined.The reported glucose values fall within the c zone of the parkes error grid.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 dr.; san diego CA 92121
• Manufacturer Contact: ying chen ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 9335892
• MDR Text Key: 166814299
• Report Number: 3004753838-2019-089257
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2020
• Device Model Number: 9500-35
• Device Catalogue Number: STS-GL-006
• Device Lot Number: 7249786
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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: 40 YR