MAUDE Adverse Event Report: DEXCOM, INC. T:SLIM G4 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 9500-27

Device Problem Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was an inaccuracy between the continuous glucose monitor (cgm) reading and the blood glucose (bg) meter reading.Reportedly, the cgm bg reading was 180 mg/dl, and the meter bg reading was 104 mg/dl.No additional patient or event information was available.A root cause could not be determined.A replacement sensor was sent to the customer.

• Brand Name: T:SLIM G4 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: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 11015119
• MDR Text Key: 221743039
• Report Number: 3013756811-2020-145039
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 36 YR