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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. T:SLIM G4 SYSTEM; CONTINUOUS GLUCOSE MONITOR
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DEXCOM, INC. T:SLIM G4 SYSTEM; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number 9438-05
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/08/2020
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 the transmitter lost connection with the pump for an unspecified duration of time.Multiple contact attempts were made by tandem technical support to obtain additional information regarding the issue; however, the customer did not respond.No additional patient or event information was available.
 
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Brand Name
T:SLIM G4 SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
MDR Report Key10763336
Report Number3013756811-2020-118197
Device Sequence Number11722691
Product Code OYC
UDI-Device Identifier10386270000047
UDI-Public(01)10386270000047
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
P140015
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) 10/30/2020
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 Number9438-05
Device Catalogue NumberSTT-GL-003
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 10/08/2020
Initial Report FDA Received Date10/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age52 YR
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