FDA.reportPublic FDA data

MAUDE MDR 9907975

MDR report key
9907975
Report number
3013756811-2020-31095
Event key
0
Event type
3
Date of event
2020-03-08
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 THE TANDEM USER GUIDE, "THE TRANSMITTER BATTERY WILL LAST AT LEAST 90 DAYS. ONCE YOU SEE THE LOW TRANSMITTER BATTERY ALERT, REPLACE THE TRANSMITTER AS SOON AS POSSIBLE." 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 FOR LONGER THAN 3 MONTHS. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. TANDEM TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO USE A NEW TRANSMITTER.