MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; CONTINOUS GLUCOSE MONITOR

Model Number MT22719

Device Problem Defective Alarm (1014)

Patient Problems Bone Fracture(s) (1870); Hypoglycemia (1912); Pain (1994)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.Product code pqf is not currently available.

Event Description

Dexcom was made aware on 01/23/2017, that on (b)(6) 2016, the patient did not hear the fixed low alert on her receiver, in addition to an adverse event that occurred.The patient stated that she woke up in middle of the night on (b)(6) 2016 and wasn't feeling good.The patient went to bathroom then back to bed and stated she did not hear her dexcom alarms.The patient states that she woke up and found her bedside table shattered and she had pain in her head and hand.The patient could not remember what had happened during the night and believes it was a low blood glucose event.The patient considered pain in hand was from rheumatoid arthritis and the patient did not seek medical attention at that time and self-medicated.On (b)(6) 2016, the patient drove herself to the emergency room (er) due to continued pain in her hand and er doctor diagnosed a broken scaffold due to event and being hypoglycemic unaware.The patient also went to orthopedic doctor on (b)(6) 2016 as follow up, regarding broken hand for adverse event on (b)(6) 2016.The doctor stated the patient may require surgery.There is no reported surgery as of yet.At time of contact the patient has a cast on her hand and is in stable condition.No additional event or patient information is available.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.An exterior visual inspection was performed and no defects were found.The receiver was observed to be re-initializing continuously.Functional testing could not be performed and a data log could not be retrieved.The case was opened for further evaluation and the interior inspection passed.Due to the condition of the device, the reported event of an intermittent audio output was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINOUS 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: 6348371
• MDR Text Key: 67923888
• Report Number: 3004753838-2017-10840
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 30386270000232
• UDI-Public: (01)30386270000232(241)STR-GF-001(10)5219345
• 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
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22719
• Device Catalogue Number: STR-GF-001
• Device Lot Number: 5219345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2016
• 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
• Treatment: NORCO HYDROCODONE 5 -325 MG (ONCE EVERY 4 HOURS)
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 113