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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC. G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS
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DEXCOM INC. G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS Back to Search Results
Model Number 9438-01
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Trial patient contacted dexcom on (b)(6) 2015 to report that on (b)(6) 2015, patient experienced an intermittent out of range signal.No additional patient or event information is available.
 
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Brand Name
G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
MDS
Manufacturer (Section D)
DEXCOM INC.
6340 sequence dr
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 Key5266207
MDR Text Key32894142
Report Number3004753838-2015-63605
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000040
UDI-Public00386270000040
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 11/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number9438-01
Device Catalogue NumberSTT-PU-001
Device Lot Number5188631
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/12/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/03/2014
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 Age47 YR
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