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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 9500-27
Medical Device Problem Code Imprecision (1307)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/03/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device not returned.
 
Event or Problem Description
It was reported that there was an inaccuracy between the continuous glucose monitor (cgm) reading and the blood glucose (bg) meter reading.Reportedly, the cgm bg reading was 40 mg/dl, and the meter bg reading was 353 mg/dl.No additional patient or event information was available.A root cause could not be determined.A replacement sensor was sent to the customer.
 
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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 Key11224232
Report Number3013756811-2021-03093
Device Sequence Number19903381
Product Code OYC
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
P140015
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Y
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/25/2021
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 Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5276051
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 01/03/2021
Initial Report FDA Received Date01/25/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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