FDA.reportPublic FDA data

MAUDE MDR 9908417

MDR report key
9908417
Report number
3013756811-2020-30377
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
1T:SLIM G5 SYSTEMCONTINUOUS GLUCOSE MONITORTANDEM DIABETES CAREOYC10000961000911R Y

Patients#

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

Event Narratives#

N

Patient 1

THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

D

Patient 1

IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. SUBSEQUENTLY, THE CUSTOMER RECEIVED A CARTRIDGE ALARM (ALARM 1). ADDITIONALLY, A MINIMUM FILL NOTIFICATION OCCURRED AFTER RELOADED THE CARTRIDGE WITH 180 UNITS OF INSULIN.?REPORTEDLY, A NEW CARTRIDGE WAS FILLED AND LOADED SUCCESSFULLY. CUSTOMER'S BLOOD GLUCOSE WAS 157 MG/DL.