FDA.reportPublic FDA data

MAUDE MDR 9908877

MDR report key
9908877
Report number
3004209178-2020-92467
Event key
0
Event type
3
Date of event
2019-10-28
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
1PUMP MMT-1782K 670G V4.11 MMARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROLMEDTRONIC PUERTO RICO OPERATIONS CO.OZPMMT-1782KMMT-1782KHG3DRN2R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

INSULIN PUMP WAS RECEIVED WITH MISSING RESERVOIR TUBE O-RING AND MISSING RESERVOIR RETAINER. THE P-CAP DOES NOT LOCK PROPERLY INTO PLACE. UNABLE TO PERFORM DISPLACEMENT TEST AND RESERVOIR UNABLE TO LOCK INTO PLACE DUE TO MISSING RESERVOIR TUBE O-RING AND MISSING RESERVOIR RETAINER. (B)(4).

D

Patient 1

INFORMATION RECEIVED BY THE MEDTRONIC INDICATED THAT THE INSULIN PUMP?S RESERVOIR LIP RING WAS POPPED OFF HOWEVER RESERVOIR WAS ABLE TO LOCK IN PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.