MAUDE Adverse Event Report: DEXCOM, INC.; MDS

Model Number 9500-27

Device Problems Use of Device Problem (1670); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter that occurred on (b)(6) 2016.The sensor was inserted on (b)(6) 2016.It was reported the patient made treatment decisions based on cgm values and at the time of contact, no injury or medical intervention was reported.The complaint device was not returned for evaluation and data was not provided; therefore, the reported complaint of inaccuracies cannot be confirmed.It was reported the transmitter was removed prior to removing the sensor pod.The dexcom continuous glucose monitoring system states: do not remove the transmitter before removing the sensor pod from your body.It was also reported the patient made treatment decisions based on cgm values.The dexcom continuous glucose monitoring system states: the dexcom continuous glucose monitoring system does not replace your bg meter.When making treatment decisions, such as the amount of insulin you need, only use your bg value.Don't use the dexcom cgm system sensor glucose readings because readings can be different from your bg value.If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event.However, a root cause for the reported inaccuracy cannot be determined.

• Brand Name: NI
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego 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: 5682613
• MDR Text Key: 46070078
• Report Number: 3004753838-2016-12581
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5209888(17)170304
• 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: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5209888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2016
• 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 Age: 38 YR