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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 MT22495
Device Problem Defective Alarm (1014)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 10/02/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced no alerts on the receiver and an adverse event. On (b)(6) 2017, the patient was at work and stated that the alarm did not sound on the receiver. It was indicated that at 9:00am, the data on the receiver was showing that they were below 80 mg/dl and then below 50 mg/dl at 9:30am. The patient walked to a meeting at 10:00am and did not remember anything after that. The patient's coworkers at the meeting noticed that the patient was not responding to conversation but did not hear any alerts and presumed that the patient was having a low event. It was indicated that 10 minutes later, the patient went into seizures and a coworker called 911. When the paramedics arrived, they checked the patient's glucose reading and it was reading 19 mg/dl. The paramedics treated the patient with glucodon and glucose gel and the patient came to. At the time of contact, the patient was doing good. No additional patient or event 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. The device was visually inspected and no defects were found. The receiver will boot and charge. The receiver download did not show any errors. A "try it" manual test try it was performed and pass. The receiver functional test was performed and pass. Open receiver case for internal visual inspection, pass. Perform speaker audio intermittent tests, pass measure the speaker resistance. Speaker resistance within specification. The reported event of an intermittent audio output was not confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS 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 Key6993968
MDR Text Key90791901
Report Number3004753838-2017-97557
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
Type of Report Initial,Followup
Report Date 10/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22495
Device Catalogue NumberSTK-DR-001
Device Lot Number5224650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/30/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/01/2017 Patient Sequence Number: 1
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