FDA.reportPublic FDA data

MAUDE MDR 9908399

MDR report key
9908399
Report number
3013756811-2020-30275
Event key
0
Event type
3
Date of event
2020-03-10
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
MICK TRIER
Address
SAN DIEGO CA 92121 US
Phone
858-858-8584
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.QBJSTT-OR-001R N

Patients#

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

Event Narratives#

N

Patient 1

PER TANDEM USER GUIDE, "IF YOU NEED TO REPLACE YOUR TRANSMITTER, YOU WILL NEED TO ENTER THE NEW TRANSMITTER ID INTO YOUR PUMP". NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAILED TRANSMITTER ERROR. REPORTEDLY, THE TRANSMITTER HAD BEEN IN USE LESS THAN 3 MONTHS. REPORTEDLY, THE CUSTOMER HAD NOT ENTERED IN THE NEW TRANSMITTER ID INTO THEIR PUMP. CUSTOMER ENTERED IN THE CORRECT TRANSMITTER ID AND WAS ABLE TO START SENSOR SESSION.