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

Model Number MT22495

Device Problem No Audible Alarm (1019)

Patient Problems Headache (1880); Confusion/ Disorientation (2553)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016 to reports no audio output from the receiver and an adverse event that occurred on (b)(6) 2016.Patient stated that on (b)(6) 2016 she was driving with her (b)(6) son, felt herself becoming disoriented with a headache and pulled the vehicle over.At some point patient grabbed her son's push up ice cream pop and ate it.Patient's husband called and walked her son through giving his mother juice.Patient also ate vanilla wafers and eventually started feeling better.No hospitalization was needed.Patient did not hear any alerts to warn her of the low at the time of event.At point of contact patient was feeling well.Additionally, patient's mother tested the receiver's alerts and they only vibrated.No additional event or patient information is available.

Manufacturer Narrative

(b)(4) describe event or problem - additional, device available for evaluation - additional, additional information/device evaluation, device evaluated by manufacturer - additional, event problem and evaluation codes - additional.

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defects were found.A "try it" manual test was performed and speaker did not sound.The reported event of no audio output was confirmed.The root cause was determined to be a defective speaker.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defects were found.A "try it" manual test was performed and speaker did not sound.The reported event of no audio output was confirmed.The root cause was determined to be a defective speaker.

Manufacturer Narrative

(b)(4).

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• Type of Device: MDS
• 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: 5719014
• MDR Text Key: 47189104
• Report Number: 3004753838-2016-03417
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000156
• UDI-Public: (01)00386270000156(241)MT22495(10)5211731(17)NI
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STR-DR-001
• Device Lot Number: 5211731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3004753838-02/29/16-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 73