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 Hypoglycemia (1912); Weakness (2145); Dizziness (2194)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that the receiver did not produce audio output and an adverse event occurred on (b)(6) 2016.Patient stated that she did not hear her low alert and experienced a low event.The patient set herself down on the floor and slowly reached into the pantry where she had a two cookies.The patient then reached for her cell phone in her purse using her cane and called her friend.Patient's friend stayed with the patient for two hours and gave her warm water until the patient's blood glucose levels were normal.Patient stated that she was unsure of what the fingerstick was reading during the low event but estimated that it was in the 30's.The patient did not check her continuous glucose monitor (cgm) at the time of the event, patient further reported that she had experienced weakness, dizziness and was light-headed during the low.Additionally, patient tested the receiver's attentive alert and it did not make a sound but only vibrated.At the time of contact, patient's condition was normal.No additional patient information was provided.The complaint device was returned for evaluation.The receiver was determined to be in good condition based on external visual inspection.A review of the receiver log found no errors related to the customer complaint.However, global receiver functional testing resulted in audio failures.Additionally, it was found that there was glue on the speaker diaphragm.The customer complaint of no audio output was confirmed.The root cause was determined to be an assembly error.

• 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: 5840303
• MDR Text Key: 50947425
• Report Number: 3004753838-2016-38924
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000156
• UDI-Public: (01)00386270000156(241)MT22495(10)5203315(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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: STK-DR-001
• Device Lot Number: 5203315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• 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: 74 YR
• Patient Weight: 49