FDA.reportPublic FDA data

MAUDE MDR 9907958

MDR report key
9907958
Report number
3004209178-2020-92379
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
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-722WWSPUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSORMEDTRONIC PUERTO RICO OPERATIONS CO.OYCMMT-722WWSMMT-722WWSA6722WWSJ* 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 A COMPROMISED FORCE SENSOR SYSTEM ALARM (A33 ALARM). THE CUSTOMER ALSO REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 300 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED THAT THEY TREATED THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE DEVICE WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM (A33). THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.