FDA.reportPublic FDA data

MAUDE MDR 9908700

MDR report key
9908700
Report number
3004209178-2020-92422
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
1530G INSULIN PUMP MMT-551NALARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPENDMEDTRONIC PUERTO RICO OPERATIONS CO.OZOMMT-551NALMMT-551NALA4551NALJ* 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.

D

Patient 1

INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM (A33 ALARM) DURING REWIND. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM AND WAS ABLE TO REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.