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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
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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT22719
Medical Device Problem Code Imprecision (1307)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/13/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem 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 G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
MDR Report Key7505423
Report Number3004753838-2018-50051
Device Sequence Number10815503
Product Code PQF
UDI-Device Identifier00386270000606
UDI-Public00386270000606
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
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) 04/13/2018
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 NumberMT22719
Device Catalogue NumberSTK-MC-001
Device Lot Number5229765
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/13/2018
Initial Report FDA Received Date05/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age68 YR
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