FDA.reportPublic FDA data

MAUDE MDR 9908849

MDR report key
9908849
Report number
3004209178-2020-92454
Event key
0
Event type
3
Date of event
2020-03-21
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
1RESERVOIR 3ML MMT-332APUMP, INFUSIONMEDTRONIC PUERTO RICO OPERATIONS CO.FRNMMT-332AMMT-332AHG2ZLQ7* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. O

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

THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 217 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED THE EVENT WAS RESOLVED BY CHANGING THE RESERVOIR. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.