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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; SENSOR, GLUCOSE, INVASIVE
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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 9438-06
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/11/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that intermittent loss of connection issues occurred between the transmitter and the pump.Reportedly, the customer replaced transmitter.No additional patient information was available.
 
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Brand Name
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Common Device Name
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
MDR Report Key10355656
Report Number3013756811-2020-81142
Device Sequence Number19555194
Product Code MDS
UDI-Device Identifier00386270000040
UDI-Public00386270000040
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
P120005
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number9438-06
Device Catalogue NumberSTT-GF-005
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/14/2020
Initial Report FDA Received Date08/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age32 YR
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