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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 PROFESSIONAL SYSTEM; CONTINUOUS GLUCOSE MONITOR
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DEXCOM, INC. DEXCOM G6 PROFESSIONAL SYSTEM; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Catalog Number STP-PR-001
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2024
Event Type  malfunction  
Event Description
It was reported that unspecified issue occurred.Data was evaluated and the allegation was confirmed as signal loss greater than an hour was confirmed.The probable cause was determined to be signal loss.The probable cause of the signal loss could not be determined.The reported event of unspecified issue occurred is reportable based on the finding of signal loss greater than an hour.No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).3191 - patient was unable to identify device issue therefore a more specific code could not be selected.4316 the concluded cause is not adequately described by any other term.
 
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Brand Name
DEXCOM G6 PROFESSIONAL SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key18981172
MDR Text Key338629991
Report Number3004753838-2024-071438
Device Sequence Number1
Product Code QII
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K182041¿
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/26/2024
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
Device Operator Lay User/Patient
Device Catalogue NumberSTP-PR-001
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/27/2024
Initial Date FDA Received03/26/2024
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
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