FDA.reportPublic FDA data

MAUDE MDR 9908179

MDR report key
9908179
Report number
3004209178-2020-92387
Event key
0
Event type
3
Date of event
2020-03-22
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-1780KPKHG322DR* 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

D

Patient 1

INFORMATION RECEIVED BY MEDTRONIC INDICATED THE USER EXPERIENCED A LOW BLOOD GLUCOSE OF 60 MG/DL AND 109 MG/DL. THE USER ALLEGED THE INSULIN PUMP WAS OVER DELIVERING INSULIN. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER WAS USING AUTO MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS AND INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.