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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
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DEXCOM, INC. DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT22430-BLU
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/08/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the receiver displayed an err46.No additional patient or event information is available.No product was returned for evaluation.The complaint could not be confirmed.A root cause could not be determined.
 
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Brand Name
DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
MDR Report Key6838071
Report Number3004753838-2017-72208
Device Sequence Number16160304
Product Code MDS
UDI-Device Identifier10386270000115
UDI-Public10386270000115
Combination Product (Y/N)N
Initial Reporter StateCA
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
Type of Report Initial
Report Date (Section B) 08/08/2017
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 NumberMT22430-BLU
Device Catalogue NumberSTK-KD-BLU
Device Lot Number5195965
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 08/08/2017
Initial Report FDA Received Date09/01/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age11 YR
Patient Weight48
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