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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 9500-27
Device Problems Use of Device Problem (1670); Invalid Sensing (2293)
Patient Problems Hypoglycemia (1912); Weakness (2145); Dizziness (2194)
Event Date 04/17/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.
 
Event Description
Dexcom was made aware on (b)(6) 2017, that on (6) 2017, the patient experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and a hypoglycemic event. The sensor was inserted into the abdomen on (b)(6) 2017. The patient indicated that her cgm read 241mg/dl with a single arrow pointed down. She then took a finger stick which read 91mg/dl. She drank juice and a few minutes later the cgm showed the double arrow pointed down. She then went downstairs to a neighbor (retired nurse) for help. The patient indicated that she could barely walk or talk. Additionally, the patient indicated that she felt dizzy and weak. The cgm alerted for the ultra low alarm (55 mg/dl). The neighbor gave the patient orange juice. Soon after, the patient's son showed up and called the paramedics. The patient's son helped the patient back to her apartment to wait for the paramedics. The paramedics checked the patient's bg, which was 72 mg/dl. The patient's son took the patient to the hospital. During the intake at the hospital, the nurse took a bg reading and the patient was at 170 mg/dl. There was no treatment given. Patient was released from the hospital the same day and was driven home by her son. At the time of contact, the patient was feeling great. No additional patient or event information is available. The patient based treatment off of cgm values. Labeling indicates: do not use the dexcom g4 platinum system for treatment decisions, such as how much insulin you should take. The dexcom g4 platinum system does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could lead to low or high blood glucose value.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM INC.
6340 sequence dr.
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key6563843
MDR Text Key75046385
Report Number3004753838-2017-26442
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)NI(17)NI
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
Type of Report Initial
Report Date 04/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/12/2017 Patient Sequence Number: 1
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