MAUDE MDR 50941433

MDR report key
50941433
Report number
3013756811-2026-177588
Event key
0
Event type
3
Date of event
2026-09-20
Date received
2026-09-30
Adverse event
0
Product problem
1
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
John Connell
Address
12400 High Bluff Drive San Diego CA 92130 US
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
418179t:slim X2 Insulin Pump with Control-IQ+ TechnologyAlternate Controller Enabled Insulin Infusion PumpTandem Diabetes CareQFG10027171014070NN
443245t:slim X2 Insulin Pump with Control-IQ+ TechnologyAlternate Controller Enabled Insulin Infusion PumpTandem Diabetes CareQFG10027171014070NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-09-300

Event Narratives#

No narrative records found.