DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM 9445-02 STS-OR-001

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 2020-03-31 for DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM 9445-02 STS-OR-001 manufactured by Dexcom, Inc..

Event Text Entries

[187029634] No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[187029635] It was reported that there was an inaccuracy between the continuous glucose monitor (cgm) reading and the blood glucose (bg) meter reading. Reportedly, the cgm bg reading was 40 mg/dl, and the meter bg reading was 160 mg/dl. No additional patient or event information was available. A root cause could not be determined. A replacement sensor was sent to the customer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3013756811-2020-31790
MDR Report Key9907981
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-08
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICK TRIER
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8584011451
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 Details

Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameCONTINUOUS GLUCOSE MONITOR
Product CodeQBJ
Date Received2020-03-31
Model Number9445-02
Catalog NumberSTS-OR-001
Lot Number5268294
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 2020-03-31

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