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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Catalog Number STS-GF-004
Device Problem Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter.The sensor was inserted at the abdomen on (b)(6) 2018.No additional event or patient information is available.No data was provided for evaluation.The complaint confirmation of the reported inaccuracy could not be determined.A root cause could not be determined.
 
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Brand Name
DEXCOM G4 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS 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 Key8182046
MDR Text Key131303684
Report Number3004753838-2018-159516
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/07/2019
Device Catalogue NumberSTS-GF-004
Device Lot Number5243759
Was Device Available for Evaluation? No
Date Manufacturer Received11/27/2018
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 Sequence Number1
Patient Age61 YR
Patient Weight65
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