FDA.reportPublic FDA data

MAUDE MDR 9908945

MDR report key
9908945
Report number
3004209178-2020-92495
Event key
0
Event type
3
Date of event
2020-01-14
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-1715K 630G BLACK MGARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPENDMEDTRONIC PUERTO RICO OPERATIONS CO.OZOMMT-1715KMMT-1715KHG2H4ZKR R

Patients#

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

Event Narratives#

N

Patient 1

PUMP WAS RECEIVED WITH A MISSING RETAINER, MISSING RESERVOIR TUBE O-RING AND CRACKED RESERVOIR TUBE LIP. THE TEST RESERVOIR DOES NOT LOCK IN PLACE AND UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO MISSING RETAINER, MISSING RESERVOIR TUBE O-RING AND CRACKED RESERVOIR TUBE LIP. (B)(4).

D

Patient 1

INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RETAINER RING ON HIS PUMP HAS BROKEN OFF. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD COSMETIC DAMAGE. THE CUSTOMER REPORTED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.