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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR Back to Search Results
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.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINOUS 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 Key6348371
MDR Text Key67923888
Report Number3004753838-2017-10840
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
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 Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719
Device Catalogue NumberSTR-GF-001
Device Lot Number5219345
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3004753838-02/29/16-001C

Patient Treatment Data
Date Received: 02/22/2017 Patient Sequence Number: 1
Treatment
NORCO HYDROCODONE 5 -325 MG (ONCE EVERY 4 HOURS)
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