FDA.reportPublic FDA data

MAUDE MDR 9908394

MDR report key
9908394
Report number
3004753838-2020-31115
Event key
0
Event type
3
Date of event
2020-03-09
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.QBJ9445-02STT-OR-0017258549R N

Patients#

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

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. DATA WAS RECEIVED FOR EVALUATION. HOWEVER, THE ALLEGED PRODUCT IS NOT PRESENT WITHIN THE INVESTIGATION WINDOW. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.