FDA.reportPublic FDA data

MAUDE MDR 9908104

MDR report key
9908104
Report number
3004209178-2020-92383
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
1640G INSULIN PUMP MMT-1711KPUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSORMEDTRONIC PUERTO RICO OPERATIONS CO.OYCMMT-1711KMMT-1711KHG40W8T* 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

D

Patient 1

IT WAS REPORTED THAT THE INSULIN PUMP HAD A CRITICAL PUMP ERROR. THE BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 6 MMOL/L. THEY STATED NO ISSUES LEADING TO THE CRITICAL PUMP ERROR. TROUBLESHOOTING WAS PROVIDED BUT NOTHING WAS RESOLVED. THE INSULIN PUMP WILL RETURN FOR ANALYSIS.