FDA.reportPublic FDA data

MAUDE MDR 9908791

MDR report key
9908791
Report number
3004209178-2020-92434
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
1PUMP MMT-1780KPK 670G PATHWAY BLACK MGARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROLMEDTRONIC PUERTO RICO OPERATIONS CO.OZPMMT-1780KPKMMT-1780KPKHG418GD* 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

IT WAS REPORTED THAT THE CUSTOMER EXPERIENCE HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 414 MG/DL. THE CUSTOMER DID NOT MENTION HOW THEY TREATED. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER HAD BEEN OFF THE INSULIN PUMP FOR LESS THAN 48 HOURS. THE AUTO MODE ON THE INSULIN PUMP WAS NOT ACTIVE AND AUTOMATICALLY ADJUSTING INSULIN DELIVERY DURING THE EVENT. CUSTOMER REPORTS CALIBRATION REQUIRED FROM THE AUTO MODE READINESS SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.