FDA.reportPublic FDA data

MAUDE MDR 9908824

MDR report key
9908824
Report number
3004209178-2020-92444
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
1670G INSULIN PUMP MMT-1780KLARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROLMEDTRONIC PUERTO RICO OPERATIONS CO.OZPMMT-1780KLMMT-1780KLHG44PUD* 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. 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

THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 47 MG/DL. THE CUSTOMER STATED THEY WERE INSULIN PUMP MAKES GRINDING NOISE WHEN IT REWINDS. IT WAS UNKNOWN WHETHER CUSTOMER USING AUTO MODE OR NOT .THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.