FDA.reportPublic FDA data

MAUDE MDR 9908424

MDR report key
9908424
Report number
3004209178-2020-92403
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
1670G INSULIN PUMP MMT-1780KLARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROLMEDTRONIC PUERTO RICO OPERATIONS CO.OZPMMT-1780KLMMT-1780KLHG3MEN4* 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

CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 433 MG/DL. IT WAS UNKNOWN IF THE INSULIN PUMP WAS ON AUTO MODE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.