DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITOR 9500-27 STS-GL-011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-27 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITOR 9500-27 STS-GL-011 manufactured by Dexcom, Inc..

Event Text Entries

[78598745] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[78598746] Dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter. The sensor was inserted into the arm on (b)(6) 2017. No additional event or patient information is available. Data was provided for evaluation. Data review confirmed the reported event of inaccurate cgm values. A root cause could not be determined via data. Labeling indicates: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites. If placed in other areas, the dexcom g5 mobile system may not function properly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004753838-2017-55206
MDR Report Key6672379
Report SourceCONSUMER
Date Received2017-06-27
Date of Report2017-06-02
Date of Event2017-06-02
Date Mfgr Received2017-06-02
Date Added to Maude2017-06-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKIPP DURBIN
Manufacturer Street6340 SEQUENCE DRIVE
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8582000200
Manufacturer G1DEXCOM, INC.
Manufacturer Street6340 SEQUENCE DRIVE
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal Code92121
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITOR
Generic NameCONTINUOUS GLUCOSE MONITOR
Product CodePQF
Date Received2017-06-27
Model Number9500-27
Catalog NumberSTS-GL-011
Lot NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerDEXCOM, INC.
Manufacturer Address6340 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121

Device Sequence Number: 1

Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITOR
Generic NameCONTINUOUS GLUCOSE MONITOR
Product CodePFQ
Date Received2017-06-27
Model Number9500-27
Catalog NumberSTS-GL-011
Lot NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEXCOM, INC.
Manufacturer Address6340 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-27

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