FDA.reportPublic FDA data

MAUDE MDR 9908747

MDR report key
9908747
Report number
3004209178-2020-92426
Event key
0
Event type
3
Date of event
2020-03-20
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
CEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777 *
Phone
818-818-8185
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWSPUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSORMEDTRONIC PUERTO RICO OPERATIONS CO.OYCMMT-754LWWSMMT-754LWWSA5754LWWSJ* 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

D

Patient 1

INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AN UNDER DELIVERY ALARM. CUSTOMER ALSO STATED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE WITH A 300 MG/DL AND TREATED WITH INSULIN PEN. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.