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

Model Number MT22495-BLU

Device Problems Use of Device Problem (1670); Device Issue (2379); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the receiver displayed a firmware error.There was no report of injury or medical intervention.No additional patient or event information is available.It was reported that a pediatric patient was using a receiver approved only for adults.It should be noted that the dexcom g4® platinum continuous glucose monitoring system states: the dexcom g4 system is not approved for use in children or adolescents, pregnant women or persons on dialysis.However, a root cause for the reported firmware error cannot be determined.It was reported that a pediatric patient was using a receiver approved only for adults.It should be noted that the dexcom g4® platinum continuous glucose monitoring system states: the dexcom g4 system is not approved for use in children or adolescents, pregnant women or persons on dialysis.The device has been received for evaluation.A follow-up report will be submitted once the evaluation is complete.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defect was found.The receiver log was reviewed and screen error alarms and firmware errors were observed.The reported event of a firmware error was confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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: 5931150
• MDR Text Key: 54028114
• Report Number: 3004753838-2016-83328
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000170
• UDI-Public: (01)00386270000170(241)MT22495-BLU(10)5214764(17)NA
• 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,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-BLU
• Device Catalogue Number: STR-DR-BLU
• Device Lot Number: 5214764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 34