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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649-1
Device Problem Defective Alarm (1014)
Patient Problems Hyperglycemia (1905); Nausea (1970)
Event Date 05/10/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the patient experienced intermittent audio output on the dexcom receiver and an adverse event.The patient felt nauseous which prompted the patient's wife to check the patient's blood sugar.It was indicated that the patient's blood glucose value was over 500mg/dl; however, neither the patient or his wife heard an alarm from the receiver.The patient's wife called for an ambulance and the patient was transported to the hospital where they were treated with insulin.The patient was in the hospital for observation until (b)(6) 2018.At the time of contact, the patient was doing fine.No additional patient or event information is available.No product or data were provided for evaluation.The reported event could not be confirmed.A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint receiver device was returned for evaluation.The device was visually inspected and no defects were found.The receiver was charged and rebooted.The receiver log was downloaded and evaluated with no related errors observed."try it" manual tests were performed and the tests passed.The receiver case was opened for an internal visual inspection and it passed.Speaker audio intermittent tests were performed and the tests passed.The speaker resistance was measured and it registered within specification.Functional testing was unable to be performed.The reported event of intermittent audio output was not confirmed.The root cause could not be determined.
 
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Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS 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 Key7611097
MDR Text Key111496599
Report Number3004753838-2018-65901
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 05/22/2018
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 NumberMT20649-1
Device Catalogue NumberSTK-GL-010
Device Lot Number5222479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/22/2018
Initial Date FDA Received06/18/2018
Supplement Dates Manufacturer Received07/19/2018
Supplement Dates FDA Received08/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age51 YR
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