FDA.reportPublic FDA data

MAUDE MDR 9908818

MDR report key
9908818
Report number
3004209178-2020-92441
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
1PUMP MMT-1780KPK 670G PATHWAY BLACK MGARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROLMEDTRONIC PUERTO RICO OPERATIONS CO.OZPMMT-1780KPKMMT-1780KPKHG3YXP7* 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

THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DISPLAY WAS BLANK. CUSTOMER BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THE BATTER CAP IS DAMAGED. THE CUSTOMER WILL BUY NEW BATTERY AND TRY TO TROUBLESHOOT THE PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.