FDA.reportPublic FDA data

MAUDE MDR 9908057

MDR report key
9908057
Report number
3013756811-2020-32844
Event key
0
Event type
3
Date of event
2020-03-03
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: YOU MUST ENTER YOUR TRANSMITTER ID CORRECTLY INTO YOUR PUMP TO RECEIVE SENSOR GLUCOSE READINGS. 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 TRANSMITTER LOST CONNECTION WITH THE PUMP FOR GREATER THAN 1 HOUR. THE TRANSMITTER ULTIMATELY REGAINED CONNECTION WITH THE PUMP. REPORTEDLY, THE CUSTOMER DID NOT HAVE THE CORRECT TRANSMITTER ID ENTERED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.