FDA.reportPublic FDA data

MAUDE MDR 9908866

MDR report key
9908866
Report number
2032227-2020-102093
Event key
0
Event type
3
Date of event
2020-03-19
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
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
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMPPUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSORMEDTRONIC MINIMEDOYCMMT-XXXMMT-XXX* N

Patients#

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

Event Narratives#

N

Patient 1

CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

D

Patient 1

INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS AND THE INSULIN WAS SQUIRTING DURING PRIME. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.