FDA.reportPublic FDA data

MAUDE MDR 9908181

MDR report key
9908181
Report number
3004753838-2020-31048
Event key
0
Event type
3
Date of event
2020-03-17
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS ASHLEY SPOTO
Address
6340 SEQUENCE DR. SAN DIEGO CA 92121 US
Phone
858-858-8582
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEMCONTINUOUS GLUCOSE MONITORDEXCOM, INC.QBJN/ASW11585N/AR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. IT WAS INDICATED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM WHICH IS PATIENT MISUSE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A LOSS OF CONNECTION WAS FOUND WITHIN THE INVESTIGATION WINDOW.?THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.