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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR

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DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2021
Event Type  malfunction  
Event Description
It was reported that an unknown dexcom issue occurred. Data was evaluated and the allegation was confirmed as signal loss greater than an hour was confirmed. The sensor was inserted into an unknown insertion side on an unknown insertion date. The probable cause was determined to be signal loss. The probable cause of the signal loss could not be determined. The reported event of an unknown dexcom issue is reportable based on the finding of signal loss greater than an hour. No injury or medical intervention was reported.
 
Manufacturer Narrative
Patient was unable to identify device issue therefore a more specific code could not be selected.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that an unknown dexcom issue occurred. Data was evaluated and the allegation was confirmed as signal loss greater than an hour was confirmed. The sensor was inserted into an unknown insertion side on an unknown insertion date. The probable cause was determined to be signal loss. The probable cause of the signal loss could not be determined. The reported event of an unknown dexcom issue is reportable based on the finding of signal loss greater than an hour. No injury or medical intervention was reported.
 
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Type of DeviceCONTINUOUS 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 Key13178614
MDR Text Key285612914
Report Number3004753838-2022-001841
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 01/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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