FDA.reportPublic FDA data

MAUDE MDR 9904912

MDR report key
9904912
Report number
3013756811-2020-31348
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
1T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGYALTERNATE CONTROLLER ENABLED INFUSION PUMPTANDEM DIABETES CAREQFG10050131002717R N

Patients#

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

Event Narratives#

N

Patient 1

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 PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. CUSTOMER'S BLOOD GLUCOSE WAS 142 MG/DL. REPORTEDLY, THE CUSTOMER CORRECTED THE PUMP TIME AND RESUMED INSULIN THERAPY.