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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 9500-44
Medical Device Problem Code Imprecision (1307)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/07/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred.The sensor was inserted into the arm on (b)(6) 2021.Data was evaluated and the allegation was confirmed.The probable cause could not be determined via data.The reported glucose values fall within the d zone of the parkes error grid.The data investigation found a difference in values that fall within the b zone of the parkes error grid.No injury or medical intervention was reported.
 
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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 dr.
san diego CA 92121
MDR Report Key11721385
Report Number3004753838-2021-73986
Device Sequence Number14280235
Product Code PQF
UDI-Device Identifier00386270000019
UDI-Public00386270000019
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P120005
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/23/2021
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 Expiration Date12/04/2021
Device Model Number9500-44
Device Catalogue NumberSTS-GF-001
Device Lot Number5283832
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 04/07/2021
Initial Report FDA Received Date04/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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