MAUDE MDR 9391588

MDR report key: 9391588
Report number: 2032227-2019-125314
Event key: 0
Event type: 3
Date of event: 2019-11-25
Date received: 2019-11-29
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: GERWIN DE GRAAFF
Address: 18000 DEVONSHIRE ST. NORTHRIDGE CA 91325 US
Phone: 818-818-8185
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR	MEDTRONIC MINIMED	OYC	MMT-XXX	MMT-XXX					*	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-29	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00853052007981	t:slim X2 5.x Insulin Pump	Tandem Diabetes Care, Inc.	OYC	2021-05-18
00763000423124	Paradigm® REAL-Time	MEDTRONIC MINIMED, INC.	OYC	2020-11-15
00763000423131	Paradigm® REAL-Time Revel™	MEDTRONIC MINIMED, INC.	OYC	2020-11-15
00853052007967	t:slim X2 5.0 Insulin Pump	Tandem Diabetes Care, Inc.	OYC	2018-10-15
00763000161088	PARADIGM® REAL-time	MEDTRONIC MINIMED, INC.	OYC	2018-09-30
00763000161132	Paradigm® REAL-Time Revel™	MEDTRONIC MINIMED, INC.	OYC	2018-09-28
00763000164300	MiniLink® REAL-Time	MEDTRONIC MINIMED, INC.	OYC	2018-07-07
10840406103106	Animas Vibe	ANIMAS CORPORATION	OYC	2018-01-15
10840406103601	Animas Vibe	ANIMAS CORPORATION	OYC	2018-01-15
10840406103137	Animas Vibe	ANIMAS CORPORATION	OYC	2018-01-15
10840406103168	Animas Vibe	ANIMAS CORPORATION	OYC	2018-01-15
10840406103199	Animas Vibe	ANIMAS CORPORATION	OYC	2018-01-15
10840406103229	Animas Vibe	ANIMAS CORPORATION	OYC	2018-01-15
00643169933125	PARADIGM® REAL-time	MEDTRONIC MINIMED, INC.	OYC	2017-11-30
00643169933170	Paradigm® REAL-Time Revel™	MEDTRONIC MINIMED, INC.	OYC	2017-11-30
20643169786725	Enlite ®	MEDTRONIC MINIMED, INC.	OYC	2017-11-25
10840406103823	Animas Vibe	ANIMAS CORPORATION	OYC	2017-09-21
10840406105261	Animas Vibe	ANIMAS CORPORATION	OYC	2017-09-21
00853052007257	t:slim X2 5.0 Insulin Pump	Tandem Diabetes Care, Inc.	OYC	2017-08-28
00853052007271	t:slim X2 5.0 Insulin Pump	Tandem Diabetes Care, Inc.	OYC	2017-08-28
00853052007295	t:slim X2 5.0 Insulin Pump	Tandem Diabetes Care, Inc.	OYC	2017-08-28
00853052007318	t:slim X2 5.0 Insulin Pump	Tandem Diabetes Care, Inc.	OYC	2017-08-28
00853052007226	t:slim X2 Cartridge, t:lock, 10 Pack	Tandem Diabetes Care, Inc.	OYC	2017-08-25
00853052007233	t:slim X2 Cartridge, t:lock, 2 Pack	Tandem Diabetes Care, Inc.	OYC	2017-08-25
20613994598404	SOF-SENSOR ®	MEDTRONIC MINIMED, INC.	OYC	2016-10-10
00643169283183	Medtronic Guardian™ Link	MEDTRONIC MINIMED, INC.	OYC	2016-09-23
00643169462724	Enlite™ Serter	MEDTRONIC MINIMED, INC.	OYC	2016-08-14
00613994933072	Enlite™ Serter	MEDTRONIC MINIMED, INC.	OYC	2016-08-14
00852162004613	t:slim G4 Insulin Pump, Reconditioned Replacement	Tandem Diabetes Care, Inc.	OYC	2016-08-11
00852162004750	t:slim G4 Insulin Pump, Reconditioned	Tandem Diabetes Care, Inc.	OYC	2016-08-11

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P140015S029	OYC	t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System	Tandem Diabetes Care, Inc.	2019-12-19
PMA	P140015S028	OYC	t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System	Tandem Diabetes Care, Inc.	2019-03-01
PMA	P140015S027	OYC	t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM	Tandem Diabetes Care, Inc.	2018-10-26
PMA	P140015S026	OYC	t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM	Tandem Diabetes Care, Inc.	2018-10-11
PMA	P130007S036	OYC	Animas Vibe System	Animas Corp.	2018-07-11

MAUDE MDR 9391588

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#