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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 MT22608-PNK
Medical Device Problem Code Defective Alarm (1014)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/02/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017 the receiver had intermittent audio output.No additional event or patient information is available.No product or data was provided for evaluation.The reported event could not be confirmed.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 Key6592913
Report Number3004753838-2017-44312
Device Sequence Number746052
Product Code PQF
UDI-Device Identifier20386270000198
UDI-Public(01)20386270000198(241)STK-CR-PNK(10)5198896
Combination Product (Y/N)N
Initial Reporter StateGA
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
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 05/02/2017
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 NumberMT22608-PNK
Device Catalogue NumberSTK-CR-PNK
Device Lot Number5198896
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/02/2017
Initial Report FDA Received Date05/25/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		3004753838-02/29/16-001C
Patient Sequence Number1
Patient Age12 YR
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