FDA.reportPublic FDA data

MAUDE MDR 9908888

MDR report key
9908888
Report number
3004209178-2020-92475
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
1630G INSULIN PUMP MMT-1715KL 630GARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPENDMEDTRONIC PUERTO RICO OPERATIONS CO.OZOMMT-1715KLMMT-1715KLHG3D814* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H

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. (B)(4).

D

Patient 1

THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER VISIT TO EMERGENCY ROOM AND THEN WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS ON (B)(6) 2020. CUSTOMER?S BLOOD GLUCOSE VALUE WAS 500 MG/DL. CUSTOMER HAD A SYMPTOM LIKE HEADACHE AND AGITATED. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUID AND INSULIN DRIP DURING HOSPITALIZATION. THE DEVICE WILL NOT RETURN FOR THE ANALYSIS.